Trial Outcomes & Findings for Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence (NCT NCT02088177)
NCT ID: NCT02088177
Last Updated: 2019-04-24
Results Overview
Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1
COMPLETED
PHASE1/PHASE2
12 participants
Weeks 1 - 8
2019-04-24
Participant Flow
This trial was conducted at the Substance Treatment and Research Service (STARS), a research clinic at Columbia University Medical Center and the New York State Psychiatric Institute in New York, NY. Participant recruitment began in October 2014 and concluded in January 2016, with data collection completed in March 2016.
All participants were assigned to treatment with injectable naltrexone under open-label conditions. The first injection was given on study day 1.
Participant milestones
| Measure |
Open Label Group
open label group receiving injections of long acting naltrexone
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Open Label Group
open label group receiving injections of long acting naltrexone
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
Baseline characteristics by cohort
| Measure |
Open Label Group
n=12 Participants
open label group receiving injections of long acting naltrexone
|
|---|---|
|
Age, Continuous
|
35.42 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 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
|
7 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
|
3 Participants
n=5 Participants
|
|
education level
High School
|
6 Participants
n=5 Participants
|
|
education level
Some College
|
1 Participants
n=5 Participants
|
|
education level
post high school technical training
|
1 Participants
n=5 Participants
|
|
education level
College Graduate
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 - 8Change in marijuana use, as measured by comparing the mean number of self reported days of marijuana use per week in the final study week, which will be week 8 or earlier if the participant discontinues as compared to the mean number of self reported days of marijuana use in week 1
Outcome measures
| Measure |
Open Label Group
n=12 Participants
open label group receiving injections of long acting naltrexone
|
|---|---|
|
Change in Marijuana Use
|
-1.7 days
Standard Deviation .51
|
PRIMARY outcome
Timeframe: Weeks 1 - 5The number of participants who accept the second injection at week 5 will be used as one measure of tolerability.
Outcome measures
| Measure |
Open Label Group
n=12 Participants
open label group receiving injections of long acting naltrexone
|
|---|---|
|
Number of Participants Receiving the Second Injection of Study Medication
|
6 Participants
|
Adverse Events
Open Label Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open Label Group
n=12 participants at risk
open label group receiving injections of long acting naltrexone
|
|---|---|
|
General disorders
insomnia
|
50.0%
6/12 • Number of events 6 • 8 weeks
|
|
Gastrointestinal disorders
nausea
|
50.0%
6/12 • Number of events 6 • 8 weeks
|
|
Gastrointestinal disorders
appetite change
|
33.3%
4/12 • Number of events 4 • 8 weeks
|
|
Injury, poisoning and procedural complications
induration
|
33.3%
4/12 • Number of events 4 • 8 weeks
|
|
Psychiatric disorders
anxiety
|
25.0%
3/12 • Number of events 3 • 8 weeks
|
|
Gastrointestinal disorders
vomitting
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
|
General disorders
irritability
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
|
General disorders
fatigue
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
General disorders
headache
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
muscle pain
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
General disorders
vivid dreams
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
diaphoresis
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
General disorders
lightheadedness
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
General disorders
chills
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
dry heaves
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place