INTERVENTIONALCOMPLETEDNCT00217971

A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction

The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2019-04-24

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 156 (ACTUAL)
Start date: 2005-03
Sponsor: New York State Psychiatric Institute
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

Delta(9)-tetrahydrocannabinol

Medicines

DRONABINOL DRONABINOL DRONABINOL DRONABINOL MARINOL Marinol MARINOL

Interventions

What was registered

DRUG

Dronabinol

Marinol

DRUG

Placebo

placebo

Source-reported results

Results posted to the registry

1 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 0
Statistical analyses: 0
Adverse-event terms: 7

PRIMARYProportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial

Time frame: weeks 7 and 8
Measure: NUMBER · participants
Reporting status: POSTED

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.

Group	N	Value	Spread / interval
Dronabinol	79	14	-
Placebo	77	12	-

Participant flow1 period

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.

Overall Study

Milestone	Dronabinol	Placebo
STARTED	79	77
COMPLETED	55	44
NOT COMPLETED	24	33

Why participants did not complete

Adverse Event: Dronabinol 1 · Placebo 1
Lost to Follow-up: Dronabinol 15 · Placebo 19

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepted

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.

primary outcomes

primary measures

Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial

Time frame: 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.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 3110fcb2-493f-4cf6-80af-fb0e767c3126
Retrieved: 11/09/2026, 14:14:52
SHA-256: 71ea826398c60d919014de12198983e22cb7126b4a35a27120bf55ea2962bb15

Event	System	Groups: affected / at risk
asthma	Respiratory, thoracic and mediastinal disorders	Dronabinol: 0 / 79 · Placebo: 1 / 77
diabetes	Endocrine disorders	Dronabinol: 1 / 79 · Placebo: 0 / 77
concussion	Injury, poisoning and procedural complications	Dronabinol: 1 / 79 · Placebo: 0 / 77
stomach flu	Gastrointestinal disorders	Dronabinol: 1 / 79 · Placebo: 0 / 77

Event	System	Groups: affected / at risk
nausea	Gastrointestinal disorders	Dronabinol: 5 / 79 · Placebo: 3 / 77
diarrhea	Gastrointestinal disorders	Dronabinol: 2 / 79 · Placebo: 6 / 77
GI upset	Gastrointestinal disorders	Dronabinol: 4 / 79 · Placebo: 2 / 77

A Randomized, Double-Blind, Placebo-Controlled Study of Dronabinol in the Treatment of Marijuana Addiction

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

Dronabinol

Placebo

Results posted to the registry

Overall Study

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Proportion of Patients Abstinent From Marijuana During Weeks 7 and 8 of the Trial

Locally readable linked articles

Age, Continuous

Sex: Female, Male

Region of Enrollment

Dronabinol

Placebo