Trial Outcomes & Findings for The Effect of Prescription Medications in Marijuana Users (NCT NCT00893074)

NCT ID: NCT00893074

Last Updated: 2017-08-03

Results Overview

Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Day 5 of the Dronabinol abstinence period
• Results posted on: 2017-08-03

Participant Flow

Participant milestones

Measure	0, 30, 60, and 120mg Dronabinol 0, 30, 60, and 120mg Dronabinol administered for 5 consecutive days in a double blind, placebo controlled study, with dose administered in a random order to the same study participants
Overall Study STARTED	24
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Prescription Medications in Marijuana Users

Baseline characteristics by cohort

Measure	Study Participant n=24 Participants Participants who received active drug as part of the study
Age, Continuous	32 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 5 of the Dronabinol abstinence period

Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).

Outcome measures

Measure	Placebo n=13 Participants 0mg daily dronabinol administered for 5 days	30mg Dronabinol n=13 Participants 30mg daily dronabinol (10mg tid) administered for 5 days	60mg Dronabinol n=13 Participants 60mg daily dronabinol (20mg tid) administered for 5 days	120mg Dronabinol n=13 Participants 120mg daily dronabinol (40mg tid) administered for 5 days
Peak Effect of Marijuana Withdrawal	4.6 units on a scale Standard Error 0.9	4.1 units on a scale Standard Error 0.9	2.9 units on a scale Standard Error 0.7	1.7 units on a scale Standard Error 0.4

PRIMARY outcome

Timeframe: Day 5 of the Dronabinol abstinence period

Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect

Outcome measures

Measure	Placebo n=13 Participants 0mg daily dronabinol administered for 5 days	30mg Dronabinol n=13 Participants 30mg daily dronabinol (10mg tid) administered for 5 days	60mg Dronabinol n=13 Participants 60mg daily dronabinol (20mg tid) administered for 5 days	120mg Dronabinol n=13 Participants 120mg daily dronabinol (40mg tid) administered for 5 days
Subjective "Drug Effect" After Smoked Marijuana	23 mm of subjective drug effect Standard Error 3	28 mm of subjective drug effect Standard Error 3	24 mm of subjective drug effect Standard Error 3	29 mm of subjective drug effect Standard Error 3

SECONDARY outcome

Timeframe: Assessed on Day 5 of dronabinol maintenance

Heart rate measured after acute cannabis exposure

Outcome measures

Measure	Placebo n=13 Participants 0mg daily dronabinol administered for 5 days	30mg Dronabinol n=13 Participants 30mg daily dronabinol (10mg tid) administered for 5 days	60mg Dronabinol n=13 Participants 60mg daily dronabinol (20mg tid) administered for 5 days	120mg Dronabinol n=13 Participants 120mg daily dronabinol (40mg tid) administered for 5 days
Heart Rate	88 beats per minutes Standard Error 2	85 beats per minutes Standard Error 2	80 beats per minutes Standard Error 1	76 beats per minutes Standard Error 1

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

30mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

60mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

120mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=24 participants at risk Placebo maintenance	30mg n=24 participants at risk 30mg dronabinol maintenance	60mg n=24 participants at risk 60mg dronabinol maintenance	120mg n=24 participants at risk 120mg dronabinol maintenance
Gastrointestinal disorders Nausea	16.7% 4/24 • Number of events 4 • 51 days	8.3% 2/24 • Number of events 2 • 51 days	8.3% 2/24 • Number of events 2 • 51 days	0.00% 0/24 • 51 days
Psychiatric disorders Anxiety	8.3% 2/24 • Number of events 2 • 51 days	8.3% 2/24 • Number of events 2 • 51 days	4.2% 1/24 • Number of events 4 • 51 days	12.5% 3/24 • Number of events 7 • 51 days
Psychiatric disorders Depression	20.8% 5/24 • Number of events 8 • 51 days	8.3% 2/24 • Number of events 3 • 51 days	12.5% 3/24 • Number of events 4 • 51 days	8.3% 2/24 • Number of events 4 • 51 days
General disorders Dry Mouth	12.5% 3/24 • Number of events 4 • 51 days	12.5% 3/24 • Number of events 5 • 51 days	12.5% 3/24 • Number of events 10 • 51 days	20.8% 5/24 • Number of events 12 • 51 days

Additional Information

Ryan Vandrey, PhD

Johns Hopkins University

Phone: 410-550-4036

Email: rvandrey@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place