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A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers.

ABSTRACT: RATIONALE:There is presently no approved single treatment for dual alcohol and nicotine dependencies. OBJECTIVE:This pilot study investigated baclofen effects in alcoholic smokers. METHODS:This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment. RESULTS:Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type. CONCLUSIONS:This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies.

SUBMITTER: Leggio L

PROVIDER: S-EPMC4278944 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers.

Leggio Lorenzo L Zywiak William H WH Edwards Steven M SM Tidey Jennifer W JW Swift Robert M RM Kenna George A GA

Psychopharmacology 20140629 1

<h4>Rationale</h4>There is presently no approved single treatment for dual alcohol and nicotine dependencies.<h4>Objective</h4>This pilot study investigated baclofen effects in alcoholic smokers.<h4>Methods</h4>This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment.<h4>Results</h4>Baclofen, compared with placebo, significantly ...[more]

PMID: 24973894

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Project description:The botanical product silymarin, an extract of milk thistle, is commonly used by patients to treat chronic liver disease and may be a treatment for NASH due to its antioxidant properties. We aimed to assess the safety and efficacy of higher than customary doses of silymarin in non-cirrhotic patients with NASH. This exploratory randomized double-blind placebo controlled multicenter Phase II trial tested a proprietary standardized silymarin preparation (Legalon®, Rottapharm|Madaus, Mylan) and was conducted at 5 medical centers in the United States. Eligible adult patients had liver biopsy within 12 months showing NASH without cirrhosis with NAFLD Activity Score (NAS) ≥4 per site pathologist's assessment. Participants were randomized to Legalon® 420 mg, 700 mg, or placebo t.i.d. for 48 weeks. The primary endpoint was histological improvement ≥2 points in NAS. Of 116 patients screened, 78 were randomized. There were no significant differences in adverse events among the treatment groups. After 48-50 weeks, 4/27 (15%) in the 700 mg dose, 5/26 (19%) participants randomized to 420 mg, and 3/25 (12%) of placebo recipients reached the primary endpoint (p = 0.79) among all randomized participants, indicating no benefit from silymarin in the intention to treat analysis Review by a central pathologist demonstrated that a substantial number of participants (49, 63%) did not meet histological entry criteria and that fibrosis stage improved most in the placebo treated group, although not significantly different from other groups. Silymarin (Legalon®) at the higher than customary doses tested in this study is safe and well tolerated. The effect of silymarin in patients with NASH remains inconclusive due to the substantial number of patients who entered the study but did not meet entry histological criteria, the lack of a statistically significant improvement in NAS of silymarin treated patients, and the unanticipated effect of placebo on fibrosis indicate the need for additional clinical trials. Trial Registration: clinicaltrials.gov, Identifier: NCT00680407.

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A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers.

Publications

A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers.

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