A Randomized,Double‐Blind,Placebo‐Controlled Trial of Naltrexone in the Treatment of Concurrent Alcohol Use Disorder and Pathological Gambling

The efficacy of naltrexone as a treatment for concurrent alcohol abuse or dependence and pathological gambling was evaluated in a randomized, double‐blind, placebo‐controlled trial. Fifty‐two, mostly male, subjects were recruited from the community and received 11 weeks of medication during which cognitive‐behavioral counseling was also provided. No significant group differences were found on any alcohol or gambling variable (ie, frequency, quantity, expenditures) at post‐treatment or at the one year follow‐up. However, a strong time effect was found suggesting that treatment, in general, was effective. The use of naltrexone to treat concurrent alcohol use and gambling problems was not supported.     

Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial

Cocaine dependence continues to be a significant problem in the United States, without any approved pharmacotherapy. Promising findings from preclinical research on the effects of cocaine on serotonin lead to examination of selective serotonin reuptake inhibitors (SSRIs) as potential treatments for cocaine dependence with mixed results, possibly due to drug interactions or specifics of concomitant behavioral therapy. The purpose of this study was to examine whether the SSRI citalopram would reduce cocaine positive urines in a 12-week, double-blind placebo-controlled trial. Seventy-six cocaine dependent patients received either citalopram 20 mg per day or placebo along with cognitive behavioral therapy (CBT) and contingency management (CM). Citalopram treated subjects showed a significant reduction in cocaine-positive urines during treatment compared to placebo treated subjects. No differences were noted in retention between the two groups. Side effects reported for citalopram were mild, with none leading to discontinuation of study drug. Results of this study support further examination of citalopram in combination with behavioral therapy as a treatment for cocaine dependence.     

Citalopram Combined with Behavioral Therapy Reduces Cocaine Use: A Double-Blind,Placebo-Controlled Trial

Cocaine dependence continues to be a significant problem in the United States, without any approved pharmacotherapy. Promising findings from preclinical research on the effects of cocaine on serotonin lead to examination of selective serotonin reuptake inhibitors (SSRIs) as potential treatments for cocaine dependence with mixed results, possibly due to drug interactions or specifics of concomitant behavioral therapy. The purpose of this study was to examine whether the SSRI citalopram would reduce cocaine positive urines in a 12-week, double-blind placebo-controlled trial.

Seventy-six cocaine dependent patients received either citalopram 20 mg per day or placebo along with cognitive behavioral therapy (CBT) and contingency management (CM). Citalopram treated subjects showed a significant reduction in cocaine-positive urines during treatment compared to placebo treated subjects. No differences were noted in retention between the two groups. Side effects reported for citalopram were mild, with none leading to discontinuation of study drug. Results of this study support further examination of citalopram in combination with behavioral therapy as a treatment for cocaine dependence.     

Treatment of cocaine and alcohol dependence with psychotherapy and disulfiram

Aims. To evaluate disulfiram and three forms of manual guided psychotherapy for individuals with cocaine dependence and concurrent alcohol abuse or dependence. Design. Randomized controlled trial. Setting. Urban substance abuse treatment center. Participants. One hundred and twenty-two cocaine/alcohol abusers (27% female; 61% African-American or Hispanic). Interventions. One of five treatments delivered over 12 weeks: cognitive behavioral treatment (CBT) plus disulfiram; Twelve Step facilitation (TSF) plus disulfiram; clinical management (CM) plus disulfiram; CBT plus no medication; TSF plus no medication. Measurements. Duration of continuous abstinence from cocaine or alcohol; frequency and quantity of cocaine and alcohol use by week, verified by urine toxicology and breathalyzer screens. Findings. Disulfiram treatment was associated with significantly better retention in treatment, as well as longer duration of abstinence from alcohol and cocaine use. The two active psychotherapies (CBT and TSF) were associated with reduced cocaine use over time compared with supportive psychotherapy (CM). Cocaine and alcohol use were strongly related throughout treatment, particularly for subjects treated with disulfiram. Conclusions. For the large proportion of cocaine-dependent individuals who also abuse alcohol, disulfiram combined with outpatient psychotherapy may be a promising treatment strategy. This study underlines (a) the significance of alcohol use among treatment-seeking cocaine abusers, (b) the promise of the strategy of treating co-morbid disorders among drug-dependent individuals, and (c) the importance of combining psychotherapy and pharmacotherapy in the treatment of drug use disorders.     

A 6-month controlled naltrexone study: combined effect with cognitive behavioral therapy in outpatient treatment of alcohol dependence

BACKGROUND: In several studies, patients with alcohol dependence treated with the opioid antagonist naltrexone have shown fewer relapses to heavy drinking than those receiving placebo. An interaction between the naltrexone effect and the type of psychological therapy has been observed. METHODS: A 6-month, double-blind, placebo-controlled, parallel-group study was performed at 10 different investigation sites. After a placebo run-in period of 1 week, 118 patients were randomized into 4 treatment groups-50 mg of naltrexone daily or placebo in combination with either cognitive behavioral therapy (CBT) or supportive therapy. The CBT was performed over nine sessions according to the manual of Project MATCH (Matching Alcoholism Treatments to Client Heterogeneity). The supportive therapy was defined as "the treatment as usual." Alcohol consumption, craving, carbohydrate-deficient transferrin, medication compliance by tablet count, and adverse clinical events were assessed at all visits. Other liver enzymes and psychiatric symptoms were also determined. RESULTS: Ninety-one (77%) patients completed the study, and 92 (78%) were 80% compliant with the medication regimen. A lower percentage of heavy-drinking days was shown in the naltrexone group (p = 0.045) compared with the placebo group, as was a lower craving score (p = 0.029). These results are supported by the lower levels of liver enzyme activities (p < 0.010 for aspartate aminotransferase, alanine aminotransferase, and gamma-glutamyltransferase), but not by the carbohydrate-deficient transferrin levels, in the naltrexone group. The mean time period before the first day of heavy drinking was longer for the group treated with CBT (p = 0.010), especially in combination with naltrexone (p = 0.007). Naltrexone was well tolerated, and no patients discontinued the study due to side effects. CONCLUSIONS: This study supports the effect of naltrexone in outpatient treatment of alcohol dependence and suggests that a beneficial interaction effect with CBT can be expected.     

Quality versus quantity: acquisition of coping skills following computerized cognitive–behavioral therapy for substance use disorders

Aims To evaluate the changes over time in quality and quantity of coping skills acquired following cognitive behavioral therapy (CBT), and examine potential mediating effects on substance use outcomes. Design A randomized controlled trial (RCT) evaluating the effectiveness of a computerized version of CBT (CBT4CBT) as an adjunct to standard out‐patient treatment over an 8‐week period. Setting Data were collected from individuals seeking treatment for substance dependence in an out‐patient community setting. Participants Fifty‐two substance abusing individuals (50% African American), with an average age of 42 years, and a majority reporting cocaine as their primary drug of choice. Measurements Participants' responses to behavioral role‐plays of situations associated with high risk for drug and alcohol use were audio‐taped and rated independently to assess their coping responses. Findings There were statistically significant increases in mean ratings of the quality of participants' coping responses for those assigned to CBT4CBT compared to treatment as usual, and these differences remained significant 3 months after treatment completion. Moreover, quality of coping responses mediated the effect of treatment on participants' duration of abstinence during the follow‐up period. Conclusions These findings suggest that assignment to the computerized CBT program improved participants' coping skills, as measured by independent ratings of a role‐playing task. It is also the first study to test and support quality of coping skills acquired as a mediator of the effect of CBT for substance use.     

Combining cognitive behavioral therapy and contingency management to enhance their effects in treating cannabis dependence: less can be more, more or less

Aims To evaluate reciprocal enhancement (combining treatments to offset their relative weaknesses) as a strategy to improve cannabis treatment outcomes. Contingency management (CM) with reinforcement for homework completion and session attendance was used as a strategy to enhance cognitive–behavioral therapy (CBT) via greater exposure to skills training; CBT was used as a strategy to enhance durability of CM with rewards for abstinence. Setting Community‐based out‐patient treatment program in New Haven, Connecticut, USA. Design Twelve‐week randomized clinical trial of four treatment conditions: CM for abstinence alone or combined with CBT, CBT alone or combined with CM with rewards for CBT session attendance and homework completion. Participants A total of 127 treatment‐seeking young adults (84.3% male, 81.1% minority, 93.7% referred by criminal justice system, average age 25.7 years). Measurements Weekly urine specimens testing positive for cannabis, days of cannabis use via the time‐line follow‐back method. Findings Within treatment, reinforcing homework and attendance did not significantly improve CBT outcomes, and the addition of CBT worsened outcomes when added to CM for abstinence (75.5 versus 57.1% cannabis‐free urine specimens, F = 2.25, P = 0.02). The CM for abstinence condition had the lowest percentage of cannabis‐negative urine specimens and the highest mean number of consecutive cannabis‐free urine specimens (3.3, F = 2.33, P = 0.02). Attrition was higher in the CBT alone condition, but random effect regression analyses indicated this condition was associated with the greatest rate of change overall. Cannabis use during the 1‐year follow‐up increased most rapidly for the two enhanced groups. Conclusions Combining contingency management and cognitive–behavioural therapy does not appear to improve success rates of treatment for cannabis dependence in clients involved with the criminal justice system.     

Initial and maintenance naltrexone treatment for alcohol dependence using primary care vs specialty care: a nested sequence of 3 randomized trials

BACKGROUND: Naltrexone may improve success in primary care treatment of alcohol dependence (AD). This study tests naltrexone and primary care management (PCM) vs naltrexone and cognitive behavior therapy (CBT) and tests naltrexone maintenance among patients who respond to an initial course of naltrexone combined with PCM vs CBT. METHODS: A nested sequence of 3 randomized trials was conducted. In study 1, 197 subjects with AD participated in a 10-week comparison of PCM and naltrexone (50 mg/d) vs CBT and naltrexone (50 mg/d). In study 2, 53 PCM responders from study 1 continued in a 24-week placebo-controlled study of maintenance naltrexone. In study 3, 60 CBT responders from study 1 continued in a 24-week placebo-controlled study of maintenance naltrexone and CBT. RESULTS: Study 1: No difference in the response to treatment; 84.1% (74/88) of the PCM patients and 86.5% (77/89) of the CBT patients avoided persistent heavy drinking. Percentage of days abstinent (PDA) declined over time for PCM vs CBT (P =.03). Study 2: Higher response maintenance for PCM and naltrexone (21/26, 80.8%) vs PCM and placebo (14/27, 51.9%; P =.03) and PDA declined more for the placebo group (P =.02). Study 3: The differences between naltrexone vs placebo on maintenance of response (25/30, 83.3% vs 21/30, 70.0%) or PDA did not reach statistical significance. CONCLUSIONS: Naltrexone yielded comparable results during the initial 10 weeks of treatment when combined with PCM or CBT. Maintenance of improvement was enhanced by continued naltrexone treatment in the PCM but not in the CBT arm.     

Predictors of Treatment Outcome in Outpatient Cocaine and Alcohol Dependence Treatment

We examined the ability of several baseline variables to predict treatment outcome in a pharmacotherapy trial that included 164 participants who were both cocaine‐ and alcohol‐dependent and were selected for a randomized, double‐blind, placebo‐controlled study. Predictor variables included results from the baseline Addiction Severity Index (ASI), initial Urine Drug Screen results, cocaine and alcohol craving and cocaine and alcohol withdrawal symptoms at the start of treatment. Successful treatment was defined as four continuous weeks of self‐reported cocaine abstinence verified by urine drug screens. In respect to demographic characteristics, there were no significant differences between patients who achieved four weeks of abstinence from cocaine and those who did not. Baseline variables that most consistently predicted cocaine abstinence included initial urine drug screen (UDS) results, the initial Cocaine Selective Severity Assessment (CSSA) scores, and initial self‐reported cocaine use in past 30 days, whereas cocaine craving, cocaine composite scores, alcohol craving, alcohol withdrawal symptoms, and alcohol composite scores did not. The results of this study suggest that cocaine dependence severity in general, and initial UDS results, the CSSA scores and frequency of recent cocaine use in particular, have a significant impact on treatment outcome in the treatment of cocaine‐dependent patients with comorbid alcoholism. Initial UDS results and CSSA scores are very useful predictors of treatment outcome and could be used as stratifying variables in outpatient cocaine and alcohol medication trials.     

Differences in Treatment Outcome among Marijuana-Dependent Young Adults with and without Antisocial Personality Disorder

Background: Few studies have addressed comorbid antisocial personality disorder (ASPD) and marijuana dependence in young adults, and results from previous studies are inconsistent. Objectives: This study evaluated differences in pretreatment characteristics and treatment outcomes between marijuana-dependent young adults with and without ASPD. Methods: Data for this study were derived from a randomized trial, in which marijuana-dependent young adults (n = 136) between 18 and 25 years of age were randomized to four behavioral conditions: (1) MET/CBT with CM, (2) MET/CBT without CM, (3) DC with CM, and (4) DC without CM. Results: Forty-four percent of the participants met DSM-IV-TR criteria for ASPD. ASPD clients had significantly more lifetime alcohol dependence disorders, marijuana use in the 28 days pretreatment, arrests, and assault and weapon charges compared to those without ASPD. ASPD clients did not differ in retention or substance use outcomes at 8 weeks posttreatment or the 6-month follow-up. In general, both groups had more attendance in the voucher condition, but there were no significant ASPD by treatment interactions. Conclusions: These data suggest that marijuana-dependent young adults with comorbid ASPD do not necessarily have poorer retention or substance use outcomes compared with marijuana-dependent young adults who do not have ASPD when treated in a well-defined behavioral therapy protocol. Scientific significance: Previous research has shown increased risks for clients with comorbid ASPD and marijuana dependence; however, our findings suggest that specialized programs for clients with ASPD may not be necessary if they are provided with empirically supported, structured treatments.     

Intermittent Marijuana Use Is Associated with Improved Retention in Naltrexone Treatment for Opiate‐Dependence

Naltrexone is a theoretically promising alternative to agonist substitution treatment for opioid dependence, but its effectiveness has been severely limited by poor adherence. This study examined, in an independent sample, a previously observed association between moderate cannabis use and improved retention in naltrexone treatment. Opioid dependent patients (N = 63), admitted for inpatient detoxification and induction onto oral naltrexone, and randomized into a six‐month trial of intensive behavioral therapy (Behavioral Naltrexone Therapy) versus a control behavioral therapy (Compliance Enhancement), were classified into three levels of cannabis use during treatment based on biweekly urine toxicology: abstinent (0% cannabis positive urine samples); intermittent use (1% to 79% cannabis positive samples); and consistent use (80% or greater cannabis positive samples). Intermittent cannabis users showed superior retention in naltrexone treatment (median days retained = 133; mean = 112.8, SE = 17.5), compared to abstinent (median = 35; mean = 47.3, SE = 9.2) or consistent users (median = 35; mean = 68.3, SE = 14.1) (log rank = 12.2, df = 2, p = .002). The effect remained significant in a Cox model after adjustment for baseline level of heroin use and during treatment level of cocaine use. Intermittent cannabis use was also associated with greater adherence to naltrexone pill‐taking. Treatment interacted with cannabis use level, such that intensive behavioral therapy appeared to moderate the adverse prognosis in the consistent cannabis use group. The association between moderate cannabis use and improved retention on naltrexone treatment was replicated. Experimental studies are needed to directly test the hypothesis that cannabinoid agonists exert a beneficial pharmacological effect on naltrexone maintenance and to understand the mechanism.     

Olanzapine in Cocaine Dependence: A Double‐Blind,Placebo‐Controlled Trial

Preclinical and uncontrolled human studies have suggested the possible efficacy of second‐generation antipsychotics, particularly olanzapine, in treating cocaine dependence. We conducted a randomized, double‐blind, placebo‐controlled trial in which 48 cocaine‐dependent subjects received olanzapine or identical‐appearing placebo for 16 weeks. The primary outcome measure was the proportion of cocaine‐negative weekly urine screens during treatment. Secondary measures included scores on a Craving Questionnaire, Addiction Severity Index subscales, and extrapyramidal symptom scales. Olanzapine and placebo did not differ on any outcome measure. Both olanzapine and placebo subjects frequently reported side effects, but no unexpected ones. We conclude that olanzapine appears ineffective for cocaine dependence.     

The impact of personality disorders on alcohol-use outcomes in a pharmacotherapy trial for alcohol dependence and comorbid Axis I disorders

Although antisocial and borderline personality disorders frequently co-occur with alcohol dependence and other Axis I disorders, their effect on alcohol use outcomes in context of pharmacotherapy remains unclear. Patients with Major Axis I disorders, including alcohol dependence, and diagnosis of antisocial (ASPD) or borderline personality disorder (BPD) were enrolled in a 12-week medication trial for treatment of their alcohol dependence. Everyone was randomized to one of four cells: naltrexone alone, placebo alone, open label disulfiram and naltrexone, or open label disulfiram and placebo. Outcome measures included scales for alcohol use and craving. Data were analyzed comparing patients with ASPD vs. those without, and patients with BPD vs. those without. Diagnosis of personality disorder did not adversely affect alcohol outcomes, and patients with ASPD or BPD did not have a poorer response to medication than patients without diagnosis of ASPD or BPD. The findings suggest that naltrexone and disulfiram can be safely and effectively used with patients who have comorbid diagnoses of Axis I and Axis II disorders.     

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Naltrexone in Outpatients With Bipolar Disorder and Alcohol Dependence

Background:  Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence. In this pilot study, the efficacy of naltrexone in reducing alcohol use and on mood symptoms was assessed in bipolar disorder and alcohol dependence.
Methods:  Fifty adult outpatients with bipolar I or II disorders and current alcohol dependence with active alcohol use were randomized to 12 weeks of naltrexone (50 mg/d) add-on therapy or placebo. Both groups received manual-driven cognitive behavioral therapy designed for patients with bipolar disorder and substance-use disorders. Drinking days and heavy drinking days, alcohol craving, liver enzymes, and manic and depressed mood symptoms were assessed.
Results:  The 2 groups were similar in baseline and demographic characteristics. Naltrexone showed trends ( p  < 0.10) toward a greater decrease in drinking days (binary outcome), alcohol craving, and some liver enzyme levels than placebo. Side effects were similar in the 2 groups. Response to naltrexone was significantly related to medication adherence.
Conclusions:  Results suggest the potential value and acceptable tolerability of naltrexone for alcohol dependence in bipolar disorder patients. A larger trial is needed to establish efficacy.     

One-year follow-up of disulfiram and psychotherapy for cocaine-alcohol users: sustained effects of treatment

Aim. To evaluate outcomes 1 year after cessation of treatment for cocaine- and alcohol-dependent individuals. Design. Randomized controlled trial. Setting. Urban substance abuse treatment center. Participants. Ninety-six of 122 subjects randomized to treatment. Interventions. One of five treatments delivered over 12 weeks. Cognitive-behavioral treatment (CBT) plus disulfiram; Twelve-Step facilitation (TSF) plus disulfiram; clinical management (CM) plus disulfiram; CBT without disulfiram; TSF without disulfiram. Measurements. Percentage of days of cocaine and alcohol use during follow-up, verified by urine toxicology screens and breathalyzer tests. Results. First, as a group, participants reported significant decreases in frequency of cocaine, but not alcohol, use after the end of treatment. Secondly, the main effects of disulfiram on cocaine and alcohol use were sustained during follow-up. Finally, initiation of abstinence for even brief periods of time within treatment was associated with significantly better outcome during follow-up. Conclusions. These findings support the efficacy of disulfiram with this challenging population and suggest that comparatively brief treatments that facilitate the initiation of abstinence may have long-term benefits.     

Treatment of cocaine-alcohol dependence with naltrexone and relapse prevention therapy

This study evaluates whether patients with cocaine-alcohol dependence might benefit from naltrexone (NTX) pharmacotherapy when delivered in conjunction with psychotherapy. Eighty outpatients meeting DSM-IV criteria for alcohol and cocaine dependence were randomly assigned to receive NTX (placebo or 50 mg/d) combined with psychotherapy (Relapse Prevention [RP] or Drug Counseling [DC]) for twelve weeks. It was hypothesized that the skills training focus of RP therapy, in combination with NTX 50 mg/d, would produce greater reductions in cocaine and alcohol use. Outcome measures included self- and objective reports of substance use, treatment retention, medication compliance, and adverse effects. During the first four weeks of treatment, the percentage of cocaine-positive urine screens was significantly lower for those receiving RP therapy (22%) than those receiving DC (47%); however, this difference subsequently diminished. No medication effects were found. All groups reported less alcohol use at the end of treatment. Treatment retention was the same among the groups, with about 33% of the subjects completing all twelve weeks of treatment. The active medication group showed better medication compliance, while the number of adverse events was low overall and not significantly different by group. In conclusion, NTX at 50 mg/d did not reduce cocaine or alcohol use. These findings stand in contrast to previously reported positive findings for NTX and RP in patients with a single diagnosis of cocaine dependence.     

Efficacy and Safety of Baclofen for Alcohol Dependence: A Randomized,Double‐Blind,Placebo‐Controlled Trial

Background: Recent clinical trials and case‐reports indicate that baclofen, a GABA_B agonist, may have efficacy for alcohol dependence. Baclofen has been shown to enhance abstinence, to reduce drinking quantity, to reduce craving, and to reduce anxiety in alcohol‐dependent individuals in 2 placebo‐controlled trials in Italy. However, the clinical trial data with baclofen is limited. The purpose of the present study was to test the efficacy and tolerability of baclofen in alcohol dependence in the United States. Methods: The study was a double‐blind, placebo‐controlled, randomized study comparing 30 mg/d of baclofen to placebo over 12 weeks of treatment and utilizing 8 sessions of BRENDA, a low‐intensity psychosocial intervention. One hundred and twenty‐one subjects were screened to yield 80 randomized subjects (44 men) with randomization balanced for gender. Percent heavy drinking days was the primary outcome measure with other drinking outcomes, anxiety levels, and craving as secondary outcomes. Tolerability was examined. Results: Seventy‐six percent of subjects completed the study. No difference by drug condition was seen in percentage of heavy drinking days where on‐average rates were 25.5% (±23.6%) for placebo and 25.9% (±23.2%) for baclofen during treatment (t₇₃ = 0.59, p = 0.56). Similarly, no differences were seen by drug condition in percentage of days abstinent, time to first drink, or time to relapse to heavy drinking. Baclofen was associated with a significant reduction in state anxiety (F_1,73 = 5.39, p = 0.02). Baclofen was well tolerated with only 2 individuals stopping baclofen because of adverse events. There were no serious adverse events. Conclusions: Baclofen, a GABA_B agonist, represents a possible new pharmacotherapeutic approach to alcohol dependence. Despite encouraging preclinical data and prior positive clinical trials with baclofen in Italy, the current trial did not find evidence that baclofen is superior to placebo in the treatment of alcohol dependence. Additional clinical trial work is necessary to establish whether baclofen does or does not have therapeutic efficacy in alcohol dependence and, if it does, what factors are predictive of response.     

A Systematic Review of Naltrexone for Attenuating Alcohol Consumption in Women with Alcohol Use Disorders

Several clinical trials have evaluated naltrexone as a treatment for alcohol use disorders (AUDs), but few have focused on women. The aim of this review was to systematically review and summarize the evidence regarding the impact of naltrexone compared to placebo for attenuating alcohol consumption in women with an AUD. A systematic review was conducted using PubMed, Cochrane, Web of Science, CINAHL, and Alcohol Studies Database to identify relevant peer‐reviewed randomized controlled trials (RCTs) published between January 1990 and August 2016. Seven published trials have evaluated the impact of naltrexone on drinking outcomes in women distinct from men; 903 alcohol‐dependent or heavy drinking women were randomized to receive once daily oral or depot (injectable) naltrexone or placebo with/without behavioral intervention. Two studies examining the quantity of drinks per day observed trends toward reduction in drinking quantity among women who received naltrexone versus placebo. The 4 studies examining the frequency of drinking had mixed results, with 1 study showing a trend that favored naltrexone, 2 showing a trend that favored placebo, and 1 that showed no difference. Two of the 3 studies examining time to relapse observed trends that tended to favor naltrexone for time to any drinking and time to heavy drinking among women who received naltrexone versus placebo. While the growing body of evidence suggests a variety of approaches to treat AUD, the impact of naltrexone to combat AUD in women is understudied. Taken together, the results suggest that naltrexone may lead to modest reductions in quantity of drinking and time to relapse, but not on the frequency of drinking in women. Future research should incorporate sophisticated study designs that examine gender differences and treatment effectiveness among those diagnosed with an AUD and present data separately for men and women.     

Anxiety disorders: treatable regardless of the severity of comorbid alcohol dependence

AIMS: Clinical and epidemiological research has shown that comorbidity is the rule rather than exception in the case of psychiatric disorders. Cognitive behavioral therapy (CBT) has been clearly demonstrated to be effective in treating anxiety and avoidance symptoms in patient samples of social phobia and agoraphobia without comorbid alcohol use disorders. It has recently been shown that treatment of comorbid anxiety disorders in alcohol-dependent patients can also be very successful. The purpose of the present study was to find predictors of treatment success for comorbid anxiety disorders in alcohol-dependent patients. METHODS: The study was conducted in a sample of 34 completers with a double diagnosis of alcohol dependence and agoraphobia or social phobia who received CBT for their comorbid anxiety disorder in a 32-week randomized controlled trial comparing alcohol and CBT anxiety disorder treatment with alcohol treatment alone. In the current report, treatment success was defined as a clinically significant change (recovery) on the anxiety discomfort scale. RESULTS: The severity of comorbid alcohol dependence did not influence the beneficial effect of CBT on the anxiety disorder. Psychological distress (SCL-90), neuroticism (NEO N), conscientiousness (NEO C), gender, employment and age of onset of alcohol dependence showed some predictive value. CONCLUSIONS: Alcohol-dependent males with a comorbid anxiety disorder seem to benefit most from CBT if their alcohol dependence started after age 25, if they are employed and if their general psychopathology is less severe. The most important conclusion, however, is that even severely alcohol-dependent patients with an anxiety disorder can benefit from psychotherapy for their anxiety disorder.     

Gender Differences in Alcohol Treatment: An Analysis of Outcome From the COMBINE Study

Background: Relatively few studies have examined gender differences in the effectiveness of specific behavioral or pharmacologic treatment of alcohol dependence. The aim of this study is to assess whether there were gender differences in treatment outcomes for specific behavioral and medication treatments singly or in combination by conducting a secondary analysis of public access data from the national, multisite NIAAA‐sponsored COMBINE study. Methods: The COMBINE study investigated alcohol treatment among 8 groups of patients (378 women, 848 men) who received medical management (MM) with 16 weeks of placebo, naltrexone (100 mg/day), acamprosate (3 g/day), or their combination with or without a specialist‐delivered combined behavioral intervention. We examined efficacy measures separately for men and women, followed by an overall analysis that included gender and its interaction with treatment condition in the analyses. These analyses were performed to confirm whether the findings reported in the parent trial were also relevant to women, and to more closely examine secondary outcome variables that were not analyzed previously for gender effects. Results: Compared to men, women reported a later age of onset of alcohol dependence by approximately 3 years, were significantly less likely to have had previous alcohol treatment, and drank fewer drinks per drinking day. Otherwise, there were no baseline gender differences in drinking measures. Outcome analyses of 2 primary (percent days abstinent and time to first heavy drinking day) and 2 secondary (good clinical response and percent heavy drinking days) drinking measures yielded the same overall pattern in each gender as that observed in the parent COMBINE study report. That is, only the naltrexone by behavioral intervention interaction reached or approached significance in women as well as in men. There was a naltrexone main effect that was significant in both men and women in reduction in alcohol craving scores with naltrexone‐treated subjects reporting lower craving than placebo‐treated subjects. Conclusions: This gender‐focused analysis found that alcohol‐dependent women responded to naltrexone with COMBINE’s Medical Management, similar to the alcohol‐dependent men, on a wide range of outcome measures. These results suggest that clinicians can feel comfortable prescribing naltrexone for alcohol dependence in both men and women. In this study, it is also notable that fewer women than men reported receiving any alcohol treatment prior to entry into the COMBINE study. Of note, women tend to go to primary health care more frequently than to specialty substance abuse programs for treatment, and so the benefit we confirm for women of the naltrexone and MM combination has practical implications for treating alcohol‐dependent women.