Dronabinol
Dronabinol titrated to 5 mg three times daily
Marinol, CSA Drug Code 7369, Schedule III, NDC 54868-3189-0Loading study record…
Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. People with schizophrenia are more likely than healthy people to abuse cannabis. Cannabis use may worsen clinical outcomes in this group, making the identification of pharmacotherapy to treat cannabis dependence in those with schizophrenia important. The investigators intend to test the combination of dronabinol, a cannabinoid agonist, and the α2-adrenergic agonist clonidine, for cannabis dependence in subjects with schizophrenia. The combination of dronabinol and clonidine may alleviate cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from medical management (MM) sessions when they are trying to stop using cannabis. The investigators propose to assess the relationship of dronabinol and clonidine, when added to MM, on cannabis use patterns in cannabis-dependent patients with schizophrenia. Hypothesis: The investigators predict that combination pharmacotherapy of dronabinol and clonidine will significantly reduce cannabis use compared to those receiving placebo.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2018-08-29
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Subjects will receive either the combination of dronabinol and clonidine or placebo in addition to medical management (MM) over a 10-week treatment period. Following treatment completion, subjects will have follow-up visits until 14 weeks after treatment initiation. This pilot study will evaluate the feasibility of the combination of dronabinol and clonidine for cannabis dependence and will establish effect sizes for a larger trial. Cannabis use disorders are highly prevalent in the United States and rising among high school seniors, making the identification of efficacious treatments for cannabis dependence of critical clinical and public health significance. Schizophrenia is overrepresented among those with cannabis dependence. At the completion of this study, the investigators hope to have improved our understanding of the relationship of the pharmacotherapy combination of dronabinol and clondine on cannabis use.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Dronabinol titrated to 5 mg three times daily
Marinol, CSA Drug Code 7369, Schedule III, NDC 54868-3189-0Clonidine 0.1 mg twice daily
Catapres, NDC 16590-266-30One placebo capsule by mouth twice daily
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Subject self-report hits of marijuana per day at week 10
Population: Only 2 of the 4 placebo subjects had Week 10 data due to dropping out of the study.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol + Clonidine | 3 | 16.91 | 14.57 |
| Placebo | 2 | 22.35 | 17.47 |
Scores on the Marijuana Craving Questionnaire (MCQ) (Heishman et al. 2009) - The 4 Factor Total Score. Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.
Population: Only 2 of the placebo subjects completed week 10 and had MCQ scores for Week 10.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol + Clonidine | 3 | 51 | 15.71 |
| Placebo | 2 | 52.33 | 15.04 |
Self-report cannabis use at 14 weeks after initiating the study.
Population: Only 1 of the placebo subjects had week 14 data due to the other week 10 completer not attending the follow-up visit at week 14.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol + Clonidine | 3 | 18.95 | 6.69 |
| Placebo | 1 | 16.29 | 0 |
Scores on the Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.
Population: Only 1 placebo subject completed Week 14 of the study and had Week 14 MCQ Total Score data.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Dronabinol + Clonidine | 3 | 54.33 | 9.29 |
| Placebo | 1 | 56 | 0 |
5 subjects that were screened were not randomized. 1 subject stopped using MJ between the screening visit and baseline visit and was thus withdrawn, 2 subjects were no longer interested in the study after screening visit, 1 subject entered in-patient treatment before randomization and 1 screened subject did not meet DSM criteria for MJ dependence
| Milestone | Dronabinol-Clonidine | Placebo |
|---|---|---|
| STARTED | 3 | 4 |
| COMPLETED | 3 | 2 |
| NOT COMPLETED | 0 | 2 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Nausea associated with Placebo | General disorders | Dronabinol + Clonidine: 0 / 3 · Placebo: 1 / 4 |
Eligibility
primary outcomes
Time frame: At 10 weeks
Subject self-report hits of marijuana per day at week 10
secondary outcomes
Time frame: At 10 weeks
Scores on the Marijuana Craving Questionnaire (MCQ) (Heishman et al. 2009) - The 4 Factor Total Score. Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.
Time frame: At 14 weeks
Self-report cannabis use at 14 weeks after initiating the study.
Time frame: At 14 weeks
Scores on the Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.
Publications
No exact PMID-linked public article is currently readable locally.