Pooled analysis of three randomized, double-blind, placebo controlled trials with rimonabant for smoking cessation

Jason D. Robinson, Paul M. Cinciripini, Maher Karam-Hage, Henri Jean Aubin, Lowell C. Dale, Raymond Niaura, Robert M. Anthenelli

Research output: Contribution to journalArticle

Abstract

Despite the withdrawal of CB1 antagonists, such as rimonabant, from the market and from active clinical development because of concerns about their side effect profiles, research suggests that the endocannabinoid system may play an important role in modulating nicotine's effects. We report the combined results, using a pooled analysis, of three previously unpublished trials assessing rimonabant as a smoking cessation pharmacotherapy conducted between 2002 and 2004. Smokers (n = 2097) motivated to quit were enrolled in three randomized, double-blind, placebo-controlled trials, STRATUS EU, US, and META, which consisted of a 10-week treatment period with either rimonabant 20 mg (n = 789), 5 mg (n = 518; used in only two of the three studies), or placebo (n = 790), in conjunction with brief counseling. The impact of drug on prolonged abstinence and adverse events was examined at 8 weeks (end-of-treatment) and at 48 weeks (available for STRATUS EU and US) after the targeted quit date. Rimonabant 20 mg resulted in significantly higher abstinence at end-of-treatment and at 48 weeks post-targeted quit date compared with placebo, while rimonabant 5 mg and placebo did not differ. Serious AEs did not differ by drug group. The 20 mg rimonabant dose, compared with placebo, produced increased nausea, diarrhea, anxiety symptoms, hyporexia, and vomiting, and decreased headache, constipation, and cough. These results support rimonabant 20 mg as a modestly effective aid for smoking cessation. Although work on CB1 antagonists such as rimonabant has mostly been stopped because of unacceptable adverse events, these results may inform and spur the development of other endocannabinoids for smoking cessation.

Original languageEnglish (US)
JournalAddiction Biology
DOIs
StateAccepted/In press - 2017

Fingerprint

rimonabant
Smoking Cessation
Placebos
Endocannabinoids
Primary Headache Disorders
Constipation
Nicotine

Keywords

  • Cannabinoid receptors
  • Pharmacotherapy
  • Rimonabant
  • Smoking cessation
  • Weight gain

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology
  • Psychiatry and Mental health

Cite this

Robinson, J. D., Cinciripini, P. M., Karam-Hage, M., Aubin, H. J., Dale, L. C., Niaura, R., & Anthenelli, R. M. (Accepted/In press). Pooled analysis of three randomized, double-blind, placebo controlled trials with rimonabant for smoking cessation. Addiction Biology. https://doi.org/10.1111/adb.12508

Pooled analysis of three randomized, double-blind, placebo controlled trials with rimonabant for smoking cessation. / Robinson, Jason D.; Cinciripini, Paul M.; Karam-Hage, Maher; Aubin, Henri Jean; Dale, Lowell C.; Niaura, Raymond; Anthenelli, Robert M.

In: Addiction Biology, 2017.

Research output: Contribution to journalArticle

Robinson, Jason D. ; Cinciripini, Paul M. ; Karam-Hage, Maher ; Aubin, Henri Jean ; Dale, Lowell C. ; Niaura, Raymond ; Anthenelli, Robert M. / Pooled analysis of three randomized, double-blind, placebo controlled trials with rimonabant for smoking cessation. In: Addiction Biology. 2017.
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