Marijuana Abuse
Conditions
Keywords
cannabis dependence, dronabinol, treatment
Brief summary
The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.
Detailed description
Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms. During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6.
Interventions
DRUGDronabinol
Dronabinol
DRUGPlacebo
placebo
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* men and women between the ages of 18-60 * Meets DSM-IV criteria for current marijuana dependence and reports marijuana as primary drug of abuse * Individuals must report using marijuana at least 5 days a week and have a marijuana positive urine drug screen on the day of study entry * Individuals must be capable of giving informed consent and capable of complying with study procedures. * Women of child-bearing age will be included in the study provided that they are not pregnant, based on the results of a blood pregnancy test drawn at the time of screening. They must also agree to use a method of contraception with proven efficacy and agree not to become pregnant during the study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be provided a full explanation of the potential dangers of pregnancy while on the study medication. If a woman becomes pregnant, the study medication will be discontinued.
Exclusion criteria
* Meets criteria for current psychiatric disorder requiring psychiatric intervention. Disorders that are stable on psychotherapy or pharmacotherapy will not be exclusionary. Individuals will be permitted to take prescribed zolpidem and zaleplon if there is no evidence of dependence on these substances. * History of seizures * Known sensitivity to dronabinol * Unstable medical conditions * Physical dependence on any other drugs (excluding nicotine) that would require medical detoxification * Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia * Pregnant or breast-feeding * Individuals who have exhibited suicidal or homicidal behavior within the past two years or who have current active suicidal ideation. * Individuals with coronary vascular disease as indicated by history of abnormal ECG or history of cardiac symptoms. * Unstable physical disorder which might make participation hazardous such as uncontrolled hypertension (SBP \> 150, DBP\> 90, or HR \> 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases \< 2-3X upper limit of normal are acceptable), or medically unstable diabetes. * Subjects in professions in which even mild intoxication would be hazardous (e.g., police officer, bus driver, firefighter). * Individuals who are court-mandated to treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial | weeks 7 and 8 | Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial. |
Countries
United States
Participant flow
Recruitment details
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
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.
Participants by arm
| Arm | Count |
|---|---|
| Dronabinol Dronabinol: 20mg bid for a daily maximum dose of 40mg. | 79 |
| Placebo Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day | 77 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Lost to Follow-up | 15 | 19 |
| Overall Study | non compliant | 1 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 12 |
Baseline characteristics
| Characteristic | Dronabinol | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 10.8 | 38.4 years STANDARD_DEVIATION 9.2 | 37.9 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment United States | 79 participants | 77 participants | 156 participants |
| Sex: Female, Male Female | 12 Participants | 16 Participants | 28 Participants |
| Sex: Female, Male Male | 67 Participants | 61 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 79 | 10 / 77 |
| serious Total, serious adverse events | 3 / 79 | 1 / 77 |
Outcome results
Primary
Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial
Timeline Followback self report data was collected. This daily report was used to assess the proportion of patients abstinent during weeks 7 and 8 of the clinical trial.
Time frame: weeks 7 and 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dronabinol | Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial | 14 participants |
| Placebo | Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial | 12 participants |