Randomised controlled trial of integrated cognitive behavioural treatment and motivational enhancement for comorbid social anxiety and alcohol use disorders.

OBJECTIVE: Alcohol use disorder and social anxiety disorder are interconnected disorders that commonly co-occur. We report the first trial to assess whether integrated treatment for social anxiety and alcohol use disorder comorbidity improves outcomes relative to standard alcohol-focussed treatment. METHOD: Participants were recruited to a randomised controlled trial, and randomly allocated to one of two treatments, Integrated (n = 61) or Control (alcohol-focussed; n = 56). Assessment and treatment session were conducted at two sites in Sydney, Australia. Inclusion criteria were as follows: (1) clinical diagnosis of social anxiety disorder and (2) Diagnosis or sub-clinical symptoms of alcohol use disorder. Diagnoses were determined according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.). All participants (n = 117) received 10 sessions of cognitive behavioural treatment and motivational enhancement. The Integrated treatment simultaneously targeted social anxiety disorder, alcohol use disorder and the connections between these disorders. The Control treatment focussed on alcohol use disorder only. Outcomes were assessed at 6-month follow-up, with interim assessments at post-treatment and 3 months. Primary outcomes were social anxiety disorder severity (composite Social Phobia Scale and Social Interaction Anxiety Scale), alcohol use disorder severity (standard drinks per day and Severity of Alcohol Dependence Questionnaire) and quality of life (Short-Form Health survey) was assessed to capture the combined impairment of social anxiety and alcohol use disorder comorbidity. RESULTS: At 6-month follow-up, both conditions showed significant reductions in social anxiety and alcohol use disorder symptoms, and improved quality of life. There was no evidence of between-condition differences for alcohol outcomes, with mean consumption reduced by 5.0 (0.8) and 5.8 (1.0) drinks per day following Alcohol and Integrated treatments, respectively. Integrated treatment achieved greater improvements in social anxiety symptoms (mean difference = -14.9, 95% confidence interval = [-28.1, -1.6], d = 0.60) and quality of life (mean difference = 7.6, 95% confidence interval = [1.2, 14.0], d = 0.80) relative to alcohol-focused treatment. CONCLUSION: These results suggest that integrated social anxiety and alcohol use disorder treatment enhances quality of life and social anxiety disorder symptom improvement, but not alcohol outcomes, compared to treatment focussed on alcohol use disorder alone.

Integrated Exposure-Based Therapy for Co-Occurring Post Traumatic Stress Disorder (PTSD) and Substance Dependence: Predictors of Change in PTSD Symptom Severity.

This paper examines factors associated with change in PTSD symptom severity among individuals randomised to receive an integrated exposure-based psychotherapy for PTSD and substance dependence-Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE). Outcomes examined include change in PTSD symptom severity as measured by the Clinician Administered PTSD Scale (CAPS), and the reliability and clinical significance of change in PTSD symptom severity. Factors examined include patient baseline characteristics, treatment characteristics, and events over follow-up. The mean difference in CAPS score was 38.24 (SE 4.81). Approximately half (49.1%) demonstrated a reliable and clinically significant improvement in PTSD symptom severity. No one was classified as having demonstrated clinically significant worsening of symptoms. Three independent predictors of reductions in PTSD symptom severity were identified: baseline PTSD symptom severity (ß 0.77, SE 0.23, p = 0.001), number of traumas experienced prior to baseline (ß -0.30, SE 0.15, p = 0.049), and number of sessions attended (ß 2.05, SE 0.87, p = 0.024). The present study provides further evidence regarding the safety of the COPE treatment and factors associated with improvement in PTSD symptom severity. The identification of only a small number of predictors of the outcome points to the broad applicability of the COPE treatment to PTSD and substance use disorder (SUD) patients.

The prevalence and correlates of secondary traumatic stress among alcohol and other drug workers in Australia.

INTRODUCTION AND AIMS: The high prevalence of trauma exposure and post-traumatic stress disorder (PTSD) among clients of alcohol and other drug (AOD) services is well documented. Less is known, however, about the impact this has on workers who assess and treat such clients. The aim of this study was to examine the prevalence and correlates of secondary traumatic stress (STS) among AOD workers in Australia. DESIGN AND METHODS: An anonymous web-based survey was undertaken and completed by 412 Australian AOD workers. The questionnaire assessed current levels of trauma training, extent of exposure to clients with a history of trauma history, AOD workers' own history of trauma exposure and PTSD, and current STS. Analyses compared individuals who currently met criteria for experiencing STS with those who did not. RESULTS: Despite the high volume of traumatised clients accessing AOD services, less than two-thirds of AOD workers reported having ever received trauma training. The prevalence rate of STS was 19.9% and was independently predicted by a higher traumatised client workload, fewer hours of clinical supervision, and stress and anxiety levels of the worker. DISCUSSION AND CONCLUSIONS: The findings highlight the importance of providing adequate trauma training and clinical supervision to AOD workers in order to maintain their health and welfare and ensure optimal treatment to clients with PTSD.

The feasibility and acceptability of a brief intervention for clients of substance use services experiencing symptoms of post traumatic stress disorder.

BACKGROUND: Trauma exposure and post traumatic stress disorder (PTSD) are common among clients of substance use services. Existing treatments for these co-occurring conditions tend to be lengthy, treatment retention is relatively poor, and they require extensive training and clinical supervision. The aim of the present study was to conduct a preliminary examination of the feasibility and acceptability of a brief intervention for PTSD symptoms among individuals seeking substance use treatment. METHODS: An uncontrolled open-label pilot study was conducted among 29 inpatients of a medicated detoxification unit in Sydney, Australia. All participants completed a baseline interview followed by the brief intervention. The intervention consists of a single, one-hour manualised session providing psychoeducation pertaining to common trauma reactions and symptom management. PTSD and substance use outcomes were assessed at 1-week, 1-month and 3-month post-intervention. RESULTS: PTSD symptom severity (assessed using the Clinicians Administered PTSD Scale) decreased significantly from baseline to 1-week follow up (ß -10.87, 95%CI: -19.75 to -1.99) and again between the 1-week and 3-month follow-ups (ß -15.38, 95%CI: -23.20 to -7.57). Despite these reductions, the majority of participants continued to meet criteria for a diagnosis of PTSD and there was no change in participants' negative post-traumatic cognitions. Participants expressed high levels of satisfaction with the intervention. CONCLUSIONS: Brief psychoeducation for traumatised clients attending substance use services appears to be feasible, acceptable, and may be of some benefit in reducing PTSD symptoms. However, participants continued to experience symptoms at severe levels; thus, brief intervention may best be conceptualised as a "stepping stone" to further trauma treatment.

Integrated care for comorbid alcohol dependence and anxiety and/or depressive disorder: study protocol for an assessor-blind, randomized controlled trial.

BACKGROUND: A major barrier to successful treatment in alcohol dependence is psychiatric comorbidity. During treatment, the time to relapse is shorter, the drop-out rate is increased, and long-term alcohol consumption is greater for those with comorbid major depression or anxiety disorder than those with an alcohol use disorder with no comorbid mental disorder. The treatment of alcohol dependence and psychological disorders is often the responsibility of different services, and this can hinder the treatment process. Accordingly, there is a need for an effective integrated treatment for alcohol dependence and comorbid anxiety and/or depression. METHODS/DESIGN: We aim to assess the effectiveness of a specialized, integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting. Following a three-week stabilization period (abstinence or significantly reduced consumption), participants will undergo complete formal assessment for anxiety and depression. Those patients with a diagnosis of an anxiety and/or depressive disorder will be randomized to either 1) integrated intervention (cognitive behavioral therapy) for alcohol, anxiety, and/or depression; or 2) usual counseling care for alcohol problems. Patients will then be followed up at weeks 12, 16, and 24. The primary outcome measure is alcohol consumption (total abstinence, time to lapse, and time to relapse). Secondary outcome measures include changes in alcohol dependence severity, depression, or anxiety symptoms and changes in clinician-rated severity of anxiety and depression. DISCUSSION: The study findings will have potential implications for clinical practice by evaluating the implementation of specialized integrated treatment for comorbid anxiety and/or depression in an alcohol outpatient service. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01941693.

An investigator-blinded, randomized study to compare the efficacy of combined CBT for alcohol use disorders and social anxiety disorder versus CBT focused on alcohol alone in adults with comorbid disorders: the Combined Alcohol Social Phobia (CASP) trial protocol.

BACKGROUND: Alcohol use disorders and social anxiety disorder are common and disabling conditions that frequently co-exist. Although there are efficacious treatments for each disorder, only two randomized controlled trials of interventions for these combined problems have been published. We developed a new integrated treatment for comorbid Social Anxiety Disorder and Alcohol Use Disorder based on established Motivational Interviewing (MI) and Cognitive Behaviour Therapy (CBT) interventions for the separate disorders. Compared to established MI/CBT for alcohol use disorders this new intervention is hypothesised to lead to greater reductions in symptoms of social anxiety and alcohol use disorder and to produce greater improvements in quality of life. Higher levels of alcohol dependence will result in relatively poorer outcomes for the new integrated treatment. METHODS/DESIGN: A randomised controlled trial comparing 9 sessions of individual integrated treatment for alcohol and social phobia with 9 sessions of treatment for alcohol use problems alone is proposed. Randomisation will be stratified for stable antidepressant use. Post treatment clinical assessments of alcohol consumption and diagnostic status at 3 and 6 month follow-up will be blind to allocation. DISCUSSION: The proposed trial addresses a serious gap in treatment evidence and could potentially define the appropriate treatment for a large proportion of adults affected by these problems. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12608000228381.

Randomized controlled trial of cognitive behaviour therapy for comorbid post-traumatic stress disorder and alcohol use disorders.

Aims This study aimed to test the efficacy of integrated cognitive behaviour therapy (CBT) for coexisting post traumatic stress disorder (PTSD) and alcohol use disorders (AUD). Setting Clinics across Sydney, Australia.Design Randomized controlled trial of 12 once-weekly individual sessions of either integrated CBT for PTSD and AUD(integrated therapy, IT; n = 33) or CBT for AUD plus supportive counselling (alcohol-support, AS; n = 29). Blind assessments were conducted at baseline and post-treatment and at 5 [standard deviation (SD) = 2.25] and 9.16(SD = 3.45) months post-treatment. Participants Sixty-two adults with concurrent PTSD and AUD. Measurements Outcomes included changes in alcohol consumption (time-line follow-back), PTSD severity [clinician-administered PTSD scale (CAPS)], alcohol dependence and problems, and depression and anxiety. Findings Reductions in PTSD severity were evident in both groups. IT participants who had received one or more sessions of exposure therapy exhibited a twofold greater rate of clinically significant change in CAPS severity at follow-up than AS participants [IT60%, AS 39%, odds ratio (OR): 2.31, 95% confidence interval (CI): 1.06, 5.01]. AS participants exhibited larger reductions than IT participants in alcohol consumption, dependence and problems within the context of greater treatment from other services during follow-up. Results lend support to a mutually maintaining effect between AUD and PTSD. Conclusions Individuals with severe and complex presentations of coexisting post-traumatic stress disorder(PTSD) and alcohol use disorders (AUD) can derive substantial benefit from cognitive behaviour therapy targeting AUD, with greater benefits associated with exposure for PTSD. Among individuals with dual disorders, these therapies can generate significant, well-maintained treatment effects on PTSD, AUD and psychopathology.

Integrated exposure-based therapy for co-occurring posttraumatic stress disorder and substance dependence: a randomized controlled trial.

CONTEXT: There is concern that exposure therapy, an evidence-based cognitive-behavioral treatment for posttraumatic stress disorder (PTSD), may be inappropriate because of risk of relapse for patients with co-occurring substance dependence. OBJECTIVE: To determine whether an integrated treatment for PTSD and substance dependence, Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE), can achieve greater reductions in PTSD and substance dependence symptom severity compared with usual treatment for substance dependence. DESIGN, SETTING, AND PARTICIPANTS: Randomized controlled trial enrolling 103 participants who met DSM-IV-TR criteria for both PTSD and substance dependence. Participants were recruited from 2007-2009 in Sydney, Australia; outcomes were assessed at 9 months postbaseline, with interim measures collected at 6 weeks and 3 months postbaseline. INTERVENTIONS: Participants were randomized to receive COPE plus usual treatment (n = 55) or usual treatment alone (control) (n = 48). COPE consists of 13 individual 90-minute sessions (ie, 19.5 hours) with a clinical psychologist. MAIN OUTCOME MEASURES: Change in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS; scale range, 0-240) and change in severity of substance dependence as measured by the number of dependence criteria met according to the Composite International Diagnostic Interview version 3.0 (CIDI; range, 0-7), from baseline to 9-month follow-up. A change of 15 points on the CAPS scale and 1 dependence criterion on the CIDI were considered clinically significant. RESULTS: From baseline to 9-month follow-up, significant reductions in PTSD symptom severity were found for both the treatment group (mean difference, -38.24 [95% CI, -47.93 to -28.54]) and the control group (mean difference, -22.14 [95% CI, -30.33 to -13.95]); however, the treatment group demonstrated a significantly greater reduction in PTSD symptom severity (mean difference, -16.09 [95% CI, -29.00 to -3.19]). No significant between-group difference was found in relation to improvement in severity of substance dependence (0.43 vs 0.52; incidence rate ratio, 0.85 [95% CI, 0.60 to 1.21), nor were there any significant between-group differences in relation to changes in substance use, depression, or anxiety. CONCLUSION: Among patients with PTSD and substance dependence, the combined use of COPE plus usual treatment, compared with usual treatment alone, resulted in improvement in PTSD symptom severity without an increase in severity of substance dependence. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN12908171.

Childhood trauma among individuals with co-morbid substance use and post traumatic stress disorder.

BACKGROUND: Little is known about the impact of childhood trauma (CT) on the clinical profile of individuals with co-occurring substance use disorder (SUD) and post traumatic stress disorder (PTSD). AIMS: To compare the clinical characteristics of individuals with SUD+PTSD who have a history of CT with SUD+PTSD individuals who have experienced trauma during adulthood only. METHOD: Data were collected on 103 individuals as part of a randomised controlled trial examining the efficacy of an integrated psychosocial treatment for SUD+PTSD. Participants were recruited from substance use treatment services, community referrals and advertising. Data were collected on demographic characteristics, substance use and treatment histories, lifetime trauma exposure, and current physical and mental health functioning. RESULTS: The vast majority (77%) of the sample had experienced at least one trauma before the age of 16, with 55% of those endorsing childhood sexual abuse. As expected individuals with a CT history, as compared to without, evidenced significantly longer duration of PTSD. Those with a CT history also had more extensive lifetime trauma exposure, an earlier age of first intoxication, and reported more severe substance use (e.g., a greater number of drug classes used in their lifetime, higher severity of dependence scores and greater number of drug treatment episodes). CONCLUSION: Individuals with co-morbid SUD+PTSD who have experienced CT present with a more severe and chronic clinical profile in relation to a number of trauma and substance use characteristics, when compared to individuals with adulthood only trauma histories. It is therefore important for SUD+PTSD treatment planning that CT be carefully assessed.

Clinical predictors of outcome from an Australian pharmacological relapse prevention trial.

AIMS: To assess which baseline characteristics of patients predict response to treatment with acamprosate (ACAMP) and naltrexone (NTX) in alcohol dependence. METHODS: Outcome data from a 12-week randomized controlled trial of NTX, ACAMP and placebo for alcohol dependence were analysed by multiple logistic regression analyses to determine the predictive effects of gender and the baseline measures of dependence severity, craving, depression, anxiety and readiness to change in addition to NTX and ACAMP treatment. Moderators of the effect of each medication on outcomes were also examined. RESULTS: Relapse was predicted by the interaction terms of ACAMP and alcohol dependence severity, NTX and depression as well as NTX and the readiness to change measure Taking Steps. Abstinence was similarly predicted by the interaction term ACAMP and alcohol dependence severity. CONCLUSION: The efficacy of NTX and ACAMP in reducing relapse or lapse is influenced by different clinical characteristics.

Some new directions for research on psychological interventions for comorbid anxiety and substance use disorders.

ISSUES: Comorbidity between anxiety and substance use disorders is common, yet it is poorly understood and poorly treated. APPROACH: Narrative literature review. PsycINFO and Medline databases were searched for clinical trials of anxiety and substance use disorders using clinical queries for 2005-2009. KEY FINDINGS: There are few well-conducted treatment outcome trials for comorbid anxiety and substance use disorders. Some recent (2005-2009) outcome literature has focused on specific mechanisms (anxiety sensitivity and tension reduction alcohol expectancies) that may underlie comorbidity between anxiety and substance use disorders and may lead to more targeted intervention. IMPLICATIONS AND CONCLUSION: The research base for understanding and treating comorbid anxiety and substance use disorders needs to be broadened. In particular research is needed with a focus on: (i) specifying particular comorbid relationships between anxiety and substance use disorders; (ii) the mechanisms that may underlie and maintain those relationships; and (iii) well-conducted evaluations of treatments that target those mechanisms.

Sample bias from different recruitment strategies in a randomised controlled trial for alcohol dependence.

INTRODUCTION AND AIMS: Participants may be recruited from diverse sources for randomised controlled trials (RCT) of treatments for alcohol dependence. A mixed recruitment strategy might facilitate recruitment and increase generalisability at the expense of introducing systematic selection bias. The current study aims to compare the effects of recruitment method on socio-demographics, baseline illness characteristics, treatment retention and treatment outcome measures. DESIGN AND METHODS: A secondary analysis from a previous 12 week RCT of naltrexone, acamprosate and placebo for alcohol dependence was conducted. Participants (n = 169) were obtained via four channels of recruitment including in-patient and outpatient referral, live media and print media solicitation. Baseline parameters, retention in treatment and treatment outcomes were compared in these groups. RESULTS: Relative to in-patient subjects, those recruited via live and print media had significantly lower scores on taking steps, less in-patient rehabilitation admissions and less previous abstinence before entering the trial. Subjects recruited via print media had significantly lower scores of alcohol dependence relative to all other modes recruitment. There were no differences between recruitment strategies on treatment retention or compliance. At outcome, no significant effect of recruitment method was detected. DISCUSSION AND CONCLUSIONS: These results suggest that different recruitment methods may be sourcing subjects with different baseline characteristics of illness. Nonetheless, these differences did not significantly impact on treatment retention or outcome, suggesting that in this population it was appropriate to recruit subjects from mixed sources.

Residential detoxification: essential for marginalised, severely alcohol- and drug-dependent individuals.

INTRODUCTION AND AIMS: In an era of health care rationalisation, residential detoxification services catering for drug- and alcohol-dependent homeless people are being closed. The principal findings of a recent evaluation of a non-medicated residential detoxification service are presented. The aims were to describe the characteristics of residents, their experience of admission, rates of withdrawal completion, referral patterns, staff and key informant perceptions of the service and its role within the wider treatment system. DESIGN AND METHODS: A process evaluation was utilised incorporating interviews with residents (n = 80) and key informants (n = 13); a survey of all service staff (n = 10); and demographic and clinical data for all residents (n = 392) admitted over one calendar year. Results. Residents were heavily substance-dependent and marginalised, with many exhibiting substantial mental and physical health impairments. Polydrug use and frequent prior engagement with drug and alcohol services were common. The majority completed withdrawal and were referred to further treatment. Residents who presented for heroin and other opiate withdrawal were more likely than other residents to leave before completing treatment (odds ratio 2.47, 95% confidence interval 1.48 - 4.15). Information from key informants, service staff and residents converged in underscoring the important role performed by the service. DISCUSSION AND CONCLUSION: Out-patient detoxification for homeless and severely drug- and alcohol-dependent populations is unrealistic. For this group, access to residential detoxification is vital as it provides an environment where potentially serious medical and psychological complications can be managed. There continues to be a clear role for supervised withdrawal in such a setting.

Do acamprosate or naltrexone have an effect on daily drinking by reducing craving for alcohol?

AIM: To explore the effect of acamprosate and naltrexone on craving and alcohol consumption in the treatment of alcohol dependence. DESIGN: A randomized, double-blind, single-dummy, placebo-controlled trial. SETTING: Three treatment centres in Sydney, Australia. PARTICIPANTS: A total of 169 alcohol-dependent subjects were given naltrexone (50 mg/day), acamprosate (1998 mg/day) or placebo for 12 weeks, in conjunction with manualized medication compliance therapy. INTERVENTION: During the course of the trial, participants kept a daily diary which included the number of standard drinks they consumed and their peak craving for alcohol that day rated on a 0-10 scale. MEASUREMENTS: Subjective ratings of daily craving and daily drinking for the first 6 weeks of treatment. FINDINGS: Mixed/hierarchical linear models were employed on an intention-to-treat basis. Analyses revealed that craving was a significant predictor of daily drinking and baseline levels of depression were the best predictor of daily craving. There was no significant improvement in model fit when treatment group was added both in models of daily craving and daily drinking. Daily alcohol consumption was best predicted by a model incorporating baseline dependence and depression scores, and daily craving, entered as a time-varying covariate. However, there was a significant craving x time x treatment interaction (t = -3.365, df = 4413.712, P < 0.001), suggesting that at higher levels of craving drinking was reduced at a significantly greater rate with naltrexone compared to acamprosate. CONCLUSIONS: Naltrexone had a greater effect on drinking when craving was high. These results support the role of naltrexone in reducing craving when that craving is highly salient. The role of acamprosate in reducing craving was not supported by these findings.

Issues with recruitment to randomised controlled trials in the drug and alcohol field: a literature review and Australian case study.

ISSUES: The randomised control trial (RCT) is a widely used tool for measuring the effectiveness of health treatments and services. However, subject recruitment is an ongoing challenge for those conducting RCTs and may have a serious impact on the success of the study and the reliability of the outcomes. APPROACH: In this review we present an examination of the problems and strategies associated with recruitment to RCTs, with particular reference to studies conducted in the drug and alcohol field. A case study of recruitment to an RCT for the treatment of alcohol dependence is presented, supplemented by PubMed, Current Contents and Medline searches to identify relevant publications. KEY FINDINGS: The literature suggests that the most common barriers to patient participation involve fears of assignment to placebo treatment, insufficient compensation and poor attendance at initial appointments. Moreover, subject referrals from staff may be a greater problem than reluctance of patients. Referrals are inhibited by complicated entry criteria, time constraints due to busy work schedules or a limited research culture. IMPLICATIONS: Subject recruitment may be promoted by financial reimbursement, close partnerships between research and referral staff; increasing the treatment group ratio in multi-drug trials to minimise randomisation to placebo; addressing negative staff attitudes; and simplifying the referral process. CONCLUSION: The need for multi-centre sites in Australian drug and alcohol treatment studies is highlighted.

The efficacy of diversion and aftercare strategies for adult drug-involved offenders: a summary and methodological review of the outcome literature.

Diversion strategies aim to redirect drug-involved offenders away from the criminal justice system and into treatment. Despite the interest in diversionary practices, the emergence of an empirical evaluation literature has been slow. A methodological review of published outcome studies was conducted to investigate the current strength of evidence for the efficacy of diversion and aftercare practices for criminal offenders. Twenty outcome studies were identified for review: 19 on diversion and one on aftercare. The vast majority of studies were non-randomised evaluations, reflecting the paucity of rigorous evaluation work in this area. Although most studies were prospective, very few reported on long-term outcomes following treatment. Detail was lacking with regard to basic study characteristics, such as eligibility criteria and outcomes. Despite these methodological shortcomings, results provide some tentative evidence that diversion and aftercare programmes could be effective. Best practice elements of diversion and aftercare programmes are identified and feasible strategies to improve the methodological quality of future evaluations are considered.

Naltrexone versus acamprosate in the treatment of alcohol dependence: A multi-centre, randomized, double-blind, placebo-controlled trial.

AIM: To compare the efficacy of acamprosate and naltrexone in the treatment of alcohol dependence. DESIGN: A double-blind, placebo-controlled trial. SETTING: Three treatment centres in Australia. PARTICIPANTS: A total of 169 alcohol dependent subjects were given naltrexone (50 mg/day), acamprosate (1998 mg/day) or placebo for 12 weeks. INTERVENTION: All subjects were offered manualized compliance therapy, a brief intervention that targets problems that may affect treatment compliance such as ambivalence and misperceptions about medication. MEASUREMENTS: Time to the first drink, time to first relapse, drinks per drinking day and cumulative abstinence. FINDINGS: In intention-to-treat analyses, there were no differences between groups on outcome measures of drinking, craving or biochemical markers. Similarly, analyses of the 94 subjects that completed the study in full and demonstrated 80% compliance, revealed no significant treatment effects. Differential treatment effects were identified after stratification according to scores on the Alcohol Dependence Scale (ADS) and Depression Anxiety and Stress Scale (DASS). A significant beneficial treatment effect on time to first relapse was revealed for subjects with 'no depression' allocated to naltrexone (n = 56; P < 0.01). In addition, a significant beneficial treatment effect was revealed in subjects with 'low dependence' allocated to naltrexone (n = 34; P < 0.05). CONCLUSIONS: The results of this study support the efficacy of naltrexone in the relapse prevention of alcoholism amongst those with low levels of clinical depression and alcohol dependence severity. No effect of acamprosate was found in our sample.

Process evaluation of an out-patient detoxification service.

This paper describes the process evaluation of an out-patient detoxification service (ODS) established by Drug Health Services (DHS) to increase the supervised withdrawal options for substance users in a Sydney metropolitan Area Health Service. The ODS aimed to provide a safe and effective supervised withdrawal to substance users who were at low risk of severe withdrawal, engage those with severe dependence in further treatment and increase the involvement of general practitioners (GPs) in the medical care of ODS clients. During its first 10 months of operation, the ODS received 199 inquiries, assessed 82 individuals and admitted 76 clients for detoxification. Withdrawal treatment proceeded without complications and within the expected time frames. Fifty-four clients completed withdrawal, 10 ceased treatment, 10 remained in treatment without completing withdrawal and two were transferred elsewhere. Clients who injected substances (mainly heroin) daily at admission, compared to others, were less likely to complete withdrawal and more likely to use a range of non-prescribed substances during withdrawal. One-fifth of clients went on to further treatment with DHS, attending at least once. Overall, the ODS met its goals, providing a safe and effective supervised withdrawal to local residents, especially women, young people and those withdrawing from benzodiazepines who had significant substance dependence, impairment and previous alcohol and other drug (AOD) treatment. Non-injecting substance users benefited most from the ODS in terms of withdrawal completion and ongoing treatment. The level of GP involvement in the conjoint care of ODS clients remained constant over time. The development and expansion of the ODS are discussed.

The efficacy of compliance therapy in pharmacotherapy for alcohol dependence: a randomized controlled trial.

OBJECTIVE: This study sought to evaluate the effectiveness of compliance therapy in increasing adherence to pharmacological treatment for alcohol dependence. METHOD: Forty subjects were randomly allocated to receive usual medical care (n = 20) or usual medical care plus compliance therapy (n = 20). All subjects were prescribed acamprosate (Campral) for 4 months. Subjects were volunteers treated at a hospital-based outpatient drug and alcohol treatment service, and were men and women who were 18-65 years old and with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of alcohol dependence. All subjects received usual medical care consisting of seven medical reviews (duration = 15 minutes) over 4 months. Compliance therapy consisted of four to six individual sessions (duration = 60 minutes) in which beliefs about medication side effects, ambivalence, the benefits of treatment, treatment maintenance and relapse prevention were addressed and explored with motivational interviewing and cognitive behavior therapy techniques. RESULTS: The outcome variables were number of days taking acamprosate, days to first drink, days to first relapse (more than five drinks) and days to first extended relapse (greater than 2 consecutive days of more than five drinks). Intention-to-treat analyses showed little difference between the two groups in the outcome drinking measures. Nevertheless, the per-protocol analyses revealed that participation in three or more sessions of compliance therapy significantly increased adherence to acamprosate and improved overall treatment outcomes. CONCLUSIONS: The present study highlights the need for psychological interventions to improve adherence to pharmacotherapy in the treatment of alcohol dependence and provides initial support for compliance therapy as an effective intervention.