Trial Outcomes & Findings for Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal (NCT NCT00480441)
NCT ID: NCT00480441
Last Updated: 2019-07-29
Results Overview
Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Baseline functional mri (fMRI), (prior to randomization)
Results posted on
2019-07-29
Participant Flow
All recruitment was conducted in West Philadelphia, PA, at the University of Pennsylvania Treatment Research Center, a facility providing treatment to study participants, between the years of 2007 and 2009.
All participants were screened with a number of medical and psychiatric evaluations prior to randomization to determine if they met study criteria.
Participant milestones
| Measure |
All Screened Participants
All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
|
Placebo 10mg QID
All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.
|
Dronabinol 10mg QID
All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.
|
|---|---|---|---|
|
Screening
STARTED
|
61
|
0
|
0
|
|
Screening
COMPLETED
|
24
|
0
|
0
|
|
Screening
NOT COMPLETED
|
37
|
0
|
0
|
|
Baseline Functional MRI
STARTED
|
24
|
0
|
0
|
|
Baseline Functional MRI
COMPLETED
|
12
|
0
|
0
|
|
Baseline Functional MRI
NOT COMPLETED
|
12
|
0
|
0
|
|
Randomization
STARTED
|
0
|
13
|
11
|
|
Randomization
COMPLETED
|
0
|
6
|
9
|
|
Randomization
NOT COMPLETED
|
0
|
7
|
2
|
Reasons for withdrawal
| Measure |
All Screened Participants
All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
|
Placebo 10mg QID
All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.
|
Dronabinol 10mg QID
All participants who were eligible for randomization, were randomized to receive either the active drug, dronabinol 10mg per dose up to 4 times per day or placebo up to 4 times per day.
|
|---|---|---|---|
|
Screening
Not Eligible
|
37
|
0
|
0
|
|
Baseline Functional MRI
Functional MRI data not usable
|
4
|
0
|
0
|
|
Baseline Functional MRI
Lost to Follow-up
|
4
|
0
|
0
|
|
Baseline Functional MRI
physical contraindication
|
4
|
0
|
0
|
|
Randomization
Lost to Follow-up
|
0
|
7
|
2
|
Baseline Characteristics
Effectiveness Study of Dronabinol and BRENDA for the Treatment of Cannabis Withdrawal
Baseline characteristics by cohort
| Measure |
Non-Randomized Participants
n=37 Participants
These were participants who consented but were excluded prior to neuroimaging and randomization because they did not meet study criteria.
|
Placebo/Dronabinol
n=24 Participants
This arm represents participants who were either given the placebo or dronabinol following the neuroimaging procedure. There was insufficient data to analyze the dronabinol and placebo groups separately due to an inability to meet statistical power considerations. Thus, for the results, the placebo and dronabinol subjects were combined into one group.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
37.6 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
38.0 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
28 participants
n=5 Participants
|
19 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
24 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline functional mri (fMRI), (prior to randomization)Population: All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
Functional MRI brain response to cannabis vs neutral cues. Higher T values represent increased blood flow in response to cues.
Outcome measures
| Measure |
All Participants
n=12 Participants
All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
|
Placebo/Dronabinol
This arm represents the participants who, following neuroimaging procedure and randomization, were given either placebo or Dronabinol
|
|---|---|---|
|
Physiological Changes in Response to Cue-induced Craving.
|
5.65 T value
|
—
|
PRIMARY outcome
Timeframe: baseline to two yearsPopulation: Non-Randomized participants were not measured because they were not included in the neuroimaging study. The only data available (summary level) is presented. Despite all good faith efforts, no access to individual data is available.
Reports of side effects leading to discontinuation of treatment were examined in all participants.
Outcome measures
| Measure |
All Participants
All participants who met preliminary criteria and consented to undergo medical and psychiatric screening to determine eligibility for study randomization.
|
Placebo/Dronabinol
n=24 Participants
This arm represents the participants who, following neuroimaging procedure and randomization, were given either placebo or Dronabinol
|
|---|---|---|
|
Tolerability of Treatment
|
—
|
0 participants
|
Adverse Events
Non-Randomized Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo/Dronabinol
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-Randomized Participants
n=37 participants at risk
37 consented subjects were determined to be ineligible for randomization.
|
Placebo/Dronabinol
n=24 participants at risk
This arm represents participants who were either given the placebo or dronabinol following the neuroimaging procedure.
|
|---|---|---|
|
Cardiac disorders
Change in Blood Pressure
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
8.3%
2/24 • Number of events 2 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Gastrointestinal disorders
Constipation/Diarrhea/
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
8.3%
2/24 • Number of events 2 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Gastrointestinal disorders
Loss of Appetite
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
4.2%
1/24 • Number of events 1 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
8.3%
2/24 • Number of events 2 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Infections and infestations
Cold/Flu Like
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
16.7%
4/24 • Number of events 4 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Nervous system disorders
Sedation/Drowsiness
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
37.5%
9/24 • Number of events 9 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Nervous system disorders
Headache
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
16.7%
4/24 • Number of events 4 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
16.7%
4/24 • Number of events 4 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
4.2%
1/24 • Number of events 1 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Psychiatric disorders
High Feeling/Euphoria
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
8.3%
2/24 • Number of events 2 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Psychiatric disorders
Increased Craving
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
25.0%
6/24 • Number of events 6 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Psychiatric disorders
Irritable
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
4.2%
1/24 • Number of events 1 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
|
Renal and urinary disorders
Createnine Elevation (mild)
|
0.00%
0/37 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
4.2%
1/24 • Number of events 1 • two years
Data was not collected separately for the Placebo and Dronabinol groups, but rather collected as a combined group.
|
Additional Information
Dr. Marina Goldman, Principle Study Investigator
Treatment Research Center
Phone: 215 222 3200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place