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Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial.

Abstract

Cannabis dependence is a substantial public health problem. Behavioral treatments have shown promise, but there are no effective medications for cannabis dependence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, in treating cannabis dependence. 156 cannabis-dependent adults were enrolled in a randomized, double-blind, placebo-controlled, 12-week trial. After a 1-week placebo lead-in phase, participants were randomized to receive dronabinol 20mg twice a day or placebo. Doses were maintained until the end of week 8 and then tapered off over 2 weeks. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow back method. There was no significant difference between treatment groups in the proportion of participants who achieved 2 weeks of abstinence at the end of the maintenance phase (dronabinol: 17.7%; placebo: 15.6%). Although both groups showed a reduction in marijuana use over time, there were no differences between the groups. Treatment retention was significantly higher at the end of the maintenance phase on dronabinol (77%), compared to placebo (61%) (P=.02), and withdrawal symptoms were significantly lower on dronabinol than placebo (P=.02). This is the first trial using an agonist substitution strategy for treatment of cannabis dependence. Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms. Future trials might test higher doses, combinations of dronabinol with other medications with complementary mechanisms, or with more potent behavioral interventions.

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  • Authors+Show Affiliations

    ,

    New York State Psychiatric Institute, Division of Substance Abuse, New York, NY 10032, USA. frl2@columbia.edu

    , , , ,

    Source

    Drug and alcohol dependence 116:1-3 2011 Jul 01 pg 142-50

    MeSH

    Adult
    Behavior, Addictive
    Cannabinoids
    Double-Blind Method
    Dronabinol
    Drug Administration Schedule
    Female
    Humans
    Male
    Marijuana Abuse
    Marijuana Smoking
    Middle Aged
    Placebos
    Psychotherapy
    Psychotropic Drugs
    Substance Withdrawal Syndrome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, N.I.H., Extramural
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    21310551

    Citation

    * When formatting your citation, note that all book, journal, and database titles should be italicized* Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Dronabinol for the treatment of cannabis dependence: a randomized, double-blind, placebo-controlled trial. AU - Levin,Frances R, AU - Mariani,John J, AU - Brooks,Daniel J, AU - Pavlicova,Martina, AU - Cheng,Wendy, AU - Nunes,Edward V, Y1 - 2011/02/18/ PY - 2010/08/27/received PY - 2010/12/13/revised PY - 2010/12/14/accepted PY - 2011/2/12/entrez PY - 2011/2/12/pubmed PY - 2012/1/14/medline SP - 142 EP - 50 JF - Drug and alcohol dependence JO - Drug Alcohol Depend VL - 116 IS - 1-3 N2 - Cannabis dependence is a substantial public health problem. Behavioral treatments have shown promise, but there are no effective medications for cannabis dependence. The purpose of this study was to evaluate the safety and efficacy of dronabinol, a synthetic form of delta-9-tetrahydrocannabinol, a naturally occurring pharmacologically active component of marijuana, in treating cannabis dependence. 156 cannabis-dependent adults were enrolled in a randomized, double-blind, placebo-controlled, 12-week trial. After a 1-week placebo lead-in phase, participants were randomized to receive dronabinol 20mg twice a day or placebo. Doses were maintained until the end of week 8 and then tapered off over 2 weeks. All participants received weekly motivational enhancement and relapse prevention therapy. Marijuana use was assessed using the timeline follow back method. There was no significant difference between treatment groups in the proportion of participants who achieved 2 weeks of abstinence at the end of the maintenance phase (dronabinol: 17.7%; placebo: 15.6%). Although both groups showed a reduction in marijuana use over time, there were no differences between the groups. Treatment retention was significantly higher at the end of the maintenance phase on dronabinol (77%), compared to placebo (61%) (P=.02), and withdrawal symptoms were significantly lower on dronabinol than placebo (P=.02). This is the first trial using an agonist substitution strategy for treatment of cannabis dependence. Dronabinol showed promise, it was well-tolerated, and improved treatment retention and withdrawal symptoms. Future trials might test higher doses, combinations of dronabinol with other medications with complementary mechanisms, or with more potent behavioral interventions. SN - 1879-0046 UR - https://www.unboundmedicine.com/medline/citation/21310551/abstract/Dronabinol_for_the_treatment_of_cannabis_dependence:_a_randomized_double_blind_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0376-8716(11)00031-7 DB - PRIME DP - Unbound Medicine ER -