Trial Outcomes & Findings for Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia (NCT NCT01598896)

NCT ID: NCT01598896

Last Updated: 2018-08-29

Results Overview

Subject self-report hits of marijuana per day at week 10

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

12 participants

Primary outcome timeframe

At 10 weeks

Results posted on

2018-08-29

Participant Flow

7 subjects were randomized for this study out of 12 subjects who were screened for this DCCS study at McLean Hospital

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screened were not randomized. 1 subject stopped using MJ between the screening visit and baseline visit and was thus withdrawn, 2 subjects were no longer interested in the study after screening visit, 1 subject entered in-patient treatment before randomization and 1 screened subject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

Participant milestones

Participant milestones
Measure	Dronabinol-Clonidine Dronabinol titrated to 5 mg three times daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine 0.1 mg twice daily Clonidine: Clonidine 0.1 mg twice daily	Placebo Placebo Placebo: One placebo capsule by mouth twice daily
Overall Study STARTED	3	4
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Dronabinol-Clonidine Dronabinol titrated to 5 mg three times daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine 0.1 mg twice daily Clonidine: Clonidine 0.1 mg twice daily	Placebo Placebo Placebo: One placebo capsule by mouth twice daily
Overall Study Withdrawal by Subject	0	1
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol + Clonidine n=3 Participants Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine: Clonidine 0.1 mg twice daily	Placebo n=4 Participants Placebo Placebo: One placebo capsule by mouth twice daily	Total n=7 Participants Total of all reporting groups
Age, Continuous	35.67 years STANDARD_DEVIATION 13.58 • n=5 Participants	30.75 years STANDARD_DEVIATION 5.91 • n=7 Participants	32.86 years STANDARD_DEVIATION 9.26 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Self-Report MJ Use	37.16 hits/day STANDARD_DEVIATION 21.92 • n=5 Participants	37.4 hits/day STANDARD_DEVIATION 19.32 • n=7 Participants	37.3 hits/day STANDARD_DEVIATION 18.63 • n=5 Participants
Marijuana Craving	65 Score on MCQ 4 Factor Total scale STANDARD_DEVIATION 10.15 • n=5 Participants	55.5 Score on MCQ 4 Factor Total scale STANDARD_DEVIATION 13.33 • n=7 Participants	59.57 Score on MCQ 4 Factor Total scale STANDARD_DEVIATION 12.2 • n=5 Participants

PRIMARY outcome

Timeframe: At 10 weeks

Population: Only 2 of the 4 placebo subjects had Week 10 data due to dropping out of the study.

Subject self-report hits of marijuana per day at week 10

Outcome measures

Outcome measures
Measure	Dronabinol + Clonidine n=3 Participants Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine: Clonidine 0.1 mg twice daily	Placebo n=2 Participants Placebo Placebo: One placebo capsule by mouth twice daily
Change From Baseline in Cannabis Use at 10 Weeks	16.91 hits/day Standard Deviation 14.57	22.35 hits/day Standard Deviation 17.47

SECONDARY outcome

Timeframe: At 10 weeks

Population: Only 2 of the placebo subjects completed week 10 and had MCQ scores for Week 10.

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.

Outcome measures

Outcome measures
Measure	Dronabinol + Clonidine n=3 Participants Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine: Clonidine 0.1 mg twice daily	Placebo n=2 Participants Placebo Placebo: One placebo capsule by mouth twice daily
Change in Craving Symptoms From Baseline at 10 Weeks	51 score on a MCQ 4 Factor Total scale Standard Deviation 15.71	52.33 score on a MCQ 4 Factor Total scale Standard Deviation 15.04

SECONDARY outcome

Timeframe: At 14 weeks

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.

Self-report cannabis use at 14 weeks after initiating the study.

Outcome measures

Outcome measures
Measure	Dronabinol + Clonidine n=3 Participants Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine: Clonidine 0.1 mg twice daily	Placebo n=1 Participants Placebo Placebo: One placebo capsule by mouth twice daily
Change From Baseline in Cannabis Use at 14 Weeks	18.95 hits/day Standard Deviation 6.69	16.29 hits/day Standard Deviation 0

SECONDARY outcome

Timeframe: At 14 weeks

Population: Only 1 placebo subject completed Week 14 of the study and had Week 14 MCQ Total Score data.

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.

Outcome measures

Outcome measures
Measure	Dronabinol + Clonidine n=3 Participants Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine: Clonidine 0.1 mg twice daily	Placebo n=1 Participants Placebo Placebo: One placebo capsule by mouth twice daily
Change in Craving Symptoms From Baseline at 14 Weeks	54.33 score on MCQ Total 4 Factor scale Standard Deviation 9.29	56 score on MCQ Total 4 Factor scale Standard Deviation 0

Adverse Events

Dronabinol + Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dronabinol + Clonidine n=3 participants at risk Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily Dronabinol: Dronabinol titrated to 5 mg three times daily Clonidine: Clonidine 0.1 mg twice daily	Placebo n=4 participants at risk Placebo Placebo: One placebo capsule by mouth twice daily
General disorders Nausea associated with Placebo	0.00% 0/3 • Adverse event data was collected every visit starting with the baseline visits up until the last visit of the study 14 weeks later.	25.0% 1/4 • Number of events 1 • Adverse event data was collected every visit starting with the baseline visits up until the last visit of the study 14 weeks later.

Additional Information

Dr. Kevin Hill

Beth Israel Deaconess Medical Center

Phone: 617-667-1504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place