Dronabinol Treatment for Marijuana Addiction - Study Results

Dronabinol Treatment for Marijuana Addiction (MARINOL)

This study has been completed.

Study NCT00217971 Information provided by New York State Psychiatric Institute

First Received on September 16, 2005. Last Updated on January 3, 2012 History of Changes

Results First Received: September 13, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Marijuana Abuse
Interventions:	Drug: Dronabinol Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All participants were seeking outpatient treatment for problems related to marijuana use and were recruited by local advertising or by clinical referrals in the New York City metropolitan area. Recruitment ran from 3/05-8/09 and patients participated in the trial at a research clinic at Columbia University.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial included a one-week placebo lead-in phase. Individuals who were able to significantly decrease their marijuana use during the first week of the study were not randomized. Participants who reported marijuana use less than twice a week during the placebo lead-in phase were considered placebo responders.

Reporting Groups

	Description
Dronabinol	Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Placebo	Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day

Participant Flow: Overall Study

	Dronabinol	Placebo
STARTED	79	77
COMPLETED	55	44
NOT COMPLETED	24	33
Adverse Event	1	1
Lost to Follow-up	15	19
Physician Decision	0	1
Withdrawal by Subject	7	12
non compliant	1	0

Baseline Characteristics

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Reporting Groups

	Description
Dronabinol	Dronabinol: 20mg bid for a daily maximum dose of 40mg.
Placebo	Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day

Baseline Measures

	Dronabinol	Placebo	Total
Number of Participants [units: participants]	79	77	156
Age [units: years] Mean ± Standard Deviation	36.9 ± 10.8	38.4 ± 9.2	37.9 ± 10.1
Gender [units: participants]
Female	12	16	28
Male	67	61	128
Region of Enrollment [units: participants]
United States	79	77	156

Outcome Measures

1. Primary:

Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial [ Time Frame: weeks 7 and 8 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Consequences of use are often long-term and more subtle. Thus, trying to initiate change over a relatively short period (i.e. patients in the present trial were maintained on the maximum dronabinol dose for only 6 weeks), may have been inadequate.

Results Point of Contact:

Name/Title: Frances R. Levin, M.D.
Organization: Columbia University
phone: (212) 543-5896
e-mail: frl2@columbia.edu

No publications provided

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00217971 History of Changes
Other Study ID Numbers:	NIDA-09236-11,#4886, P50DA009236, P50DA009236-11, DPMC
Study First Received:	September 16, 2005
Results First Received:	September 13, 2011
Last Updated:	January 3, 2012
Health Authority:	United States: Food and Drug Administration