This study evaluated the serotonergic antidepressant nefazodone versus placebo and specific cognitive-behavioral therapy (CBT) versus nondirective group counseling (GC) for relapse prevention in alcohol dependence in a large prospective, randomized, and placebo-controlled double-blind study at 3 German university centers.
242 male patients fulfilling at least 5 criteria for alcohol dependence according to DSM-IV and ICD-10 were eligible, after detoxification, for one of the following treatment combinations: nefazodone + CBT, nefazodone + GC, placebo + CBT, and placebo + GC. Either nefazodone or placebo was administered throughout the evaluation period of 15 months. Either CBT or GC was applied during the first 12 weeks as group therapy according to operationalized manuals. The main outcome measures (assessed at 3 and 12 months of treatment) were the cumulative number of abstinent days, the amount of ethanol consumed during specified evaluation periods of 3 and 12 months, the number of relapses, and the duration of time until first relapse.
After 12 weeks of treatment, no statistically significant differences were observed between the 4 treatment combinations in any outcome measure. After 52 weeks, the only significant difference was observed in the amount of ethanol consumed, with the nefazodone + GC group showing higher alcohol intake than the other 3 groups.
The results from this carefully designed clinical trial suggest that the 4 treatment combinations do not differ substantially in their efficacy for relapse prevention in nondepressed, severely alcohol-dependent patients. Nefazodone might even increase the risk of consuming a larger amount of ethanol per relapse in a subset of patients. CBT as performed in this study was associated with little additional benefit compared with structured GC.
"In control conditions (Treatment as Usual; TAU) for substance use disorders, typically only about 13% of participants achieve abstinence . Abstinence rates for treatments designed to augment TAU vary widely - ranging from 14-60%[2-5] - depending on the outcome variable and primary endpoint selected. Currently, the best treatments for cocaine and other stimulant use disorders are behavioral treatments that combine cognitive behavioral therapy (CBT) with contingency management [1,6]. "
[Show abstract][Hide abstract] ABSTRACT: Background
There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study.
STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other participants may be exercising at the same time. Following the 12-week acute phase, participants will begin a 6-month continuation phase during which time they will attend one weekly supervised DEI or HEI session.
Clinical Trials Registry
[Show abstract][Hide abstract] ABSTRACT: This article presents the proceedings of a symposium at the 2004 International Society for Biomedical Research on Alcoholism meeting in Heidelberg/Mannheim, Germany, put together by the German Society of Addiction Therapy and Research (DG-Sucht e.V.). The aim was to give an overview on recent findings from animal to human studies that were conducted by several research groups engaged in the alcoholism field in Germany for longer periods. Results of his animal studies were presented by J. Wolfgramm; G. Buehringer reported on epidemiologic and psychotherapeutic research advances on alcohol-related disorders in Germany. L. G. Schmidt summarized results of novel diagnostic and therapeutic approaches in alcohol dependence, and J. Boening focused on biopsychological personality traits as predictors for relapse in alcoholism. Data relating hyperhomocysteinemia and brain shrinkage in patients with alcoholism were presented by J. Kornhuber. Four addiction research networks federally funded represented their results in separate symposia and were therefore deliberately excluded from this symposium.
Alcoholism Clinical and Experimental Research 08/2005; 29(7):1282-7. DOI:10.1097/01.ALC.0000171897.16149.E7 · 3.21 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This meta-analysis examined 53 controlled trials of cognitive-behavioral treatment (CBT) for adults diagnosed with alcohol- or illicit-drug-use disorders. The aims were to provide an overall picture of CBT treatment efficacy and to identify client or treatment factors predictive of CBT effect magnitude.
The inverse variance weighted effect size (Hedges' g) was calculated for each study and pooled using fixed and random effects methods. Potential study-level moderators were assessed in subgroup analyses by primary drug, type of CBT, and type of comparison condition. In addition, seven client and treatment variables were examined in meta-regression analyses.
Across studies, CBT produced a small but statistically significant treatment effect (g = 0.154, p < .005). The pooled effect was somewhat lower at 6-9 months (g = 0.1 15, p < .005) and continued to diminish at 12-month follow-up (g = 0.096, p < .05). The effect of CBT was largest in marijuana studies (g = 0.513, p < .005) and in studies with a no-treatment control as the comparison condition (g = 0.796, p < .005). Meta-regression analyses indicated that the percentage of female participants was positively associated and the number of treatment sessions was negatively associated with effect size.
The findings demonstrate the utility of CBT across a large and diverse sample of studies and under rigorous conditions for establishing efficacy. CBT effects were strongest with marijuana users, when CBT was compared with no treatment, and may be larger with women than with men and when delivered in a brief format.
Journal of studies on alcohol and drugs 07/2009; 70(4):516-27. DOI:10.15288/jsad.2009.70.516 · 2.76 Impact Factor
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