Trial Outcomes & Findings for UH3 Varenicline for Cannabis Use Disorder (NCT NCT03980561)
NCT ID: NCT03980561
Last Updated: 2024-01-18
Results Overview
Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
174 participants
Primary outcome timeframe
Treatment phase Weeks 6-12
Results posted on
2024-01-18
Participant Flow
Participant milestones
| Measure |
Varenicline
2 mg daily
Varenicline: Active medication
|
Placebo
2 mg daily
Placebo: Inactive medication
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
84
|
|
Overall Study
COMPLETED
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
29
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UH3 Varenicline for Cannabis Use Disorder
Baseline characteristics by cohort
| Measure |
Varenicline
n=90 Participants
2 mg daily
Varenicline: Active medication
|
Placebo
n=84 Participants
2 mg daily
Placebo: Inactive medication
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
84 participants
n=7 Participants
|
174 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment phase Weeks 6-12Population: Week 6 participants
Cannabis use reduction was measured by daily substance use logs/self-report and examined as the total number of use sessions reported at each weekly visit.
Outcome measures
| Measure |
Varenicline
n=68 Participants
2 mg daily
Varenicline: Active medication
|
Placebo
n=63 Participants
2 mg daily
Placebo: Inactive medication
|
|---|---|---|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 11
|
8.4 number of weekly use sessions
Standard Deviation 7.5
|
11.8 number of weekly use sessions
Standard Deviation 12.8
|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 12
|
8.4 number of weekly use sessions
Standard Deviation 8.6
|
11.5 number of weekly use sessions
Standard Deviation 11.1
|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 6
|
10.3 number of weekly use sessions
Standard Deviation 8.2
|
11.6 number of weekly use sessions
Standard Deviation 11.4
|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 7
|
9.4 number of weekly use sessions
Standard Deviation 8.2
|
11.7 number of weekly use sessions
Standard Deviation 11.4
|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 8
|
9.4 number of weekly use sessions
Standard Deviation 7.9
|
10.5 number of weekly use sessions
Standard Deviation 11.3
|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 9
|
8.5 number of weekly use sessions
Standard Deviation 7.6
|
9.7 number of weekly use sessions
Standard Deviation 10.2
|
|
Efficacy of Varenicline vs. Placebo for Reducing Total Number of Weekly Cannabis Use Sessions
Week 10
|
9.2 number of weekly use sessions
Standard Deviation 7.7
|
10.7 number of weekly use sessions
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 12 weeks (across the active treatment period)Population: Participants reporting an adverse event during 12 week active treatment period
Comparing the frequency of participant-reported treatment-emergent AEs between treatment groups. Of particular interest will be AEs leading to medication discontinuation and the occurrence of treatment-related serious AEs.
Outcome measures
| Measure |
Varenicline
n=81 Participants
2 mg daily
Varenicline: Active medication
|
Placebo
n=70 Participants
2 mg daily
Placebo: Inactive medication
|
|---|---|---|
|
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Adverse events resulting in temporary or permanent medication discontinuation
|
26 number of adverse events
|
14 number of adverse events
|
|
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
All reported adverse events
|
406 number of adverse events
|
300 number of adverse events
|
|
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Medication-related adverse events
|
238 number of adverse events
|
115 number of adverse events
|
|
Safety and Tolerability of Varenicline vs. Placebo When Used for Cannabis Use Disorder
Serious adverse events related to treatment
|
0 number of adverse events
|
—
|
Adverse Events
Varenicline
Serious events: 1 serious events
Other events: 81 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=90 participants at risk
2 mg daily
Varenicline: Active medication
|
Placebo
n=84 participants at risk
2 mg daily
Placebo: Inactive medication
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.1%
1/90 • Number of events 1 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
0.00%
0/84 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
Other adverse events
| Measure |
Varenicline
n=90 participants at risk
2 mg daily
Varenicline: Active medication
|
Placebo
n=84 participants at risk
2 mg daily
Placebo: Inactive medication
|
|---|---|---|
|
Psychiatric disorders
anxiety/depression
|
13.3%
12/90 • Number of events 13 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
17.9%
15/84 • Number of events 17 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
Metabolism and nutrition disorders
decreased appetite
|
13.3%
12/90 • Number of events 12 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
13.1%
11/84 • Number of events 11 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
General disorders
dream disturbance
|
45.6%
41/90 • Number of events 54 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
25.0%
21/84 • Number of events 32 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
General disorders
fatigue
|
7.8%
7/90 • Number of events 7 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
4.8%
4/84 • Number of events 4 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
General disorders
headache
|
17.8%
16/90 • Number of events 21 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
29.8%
25/84 • Number of events 28 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
General disorders
insomnia
|
26.7%
24/90 • Number of events 24 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
23.8%
20/84 • Number of events 22 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
General disorders
irritability
|
12.2%
11/90 • Number of events 13 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
13.1%
11/84 • Number of events 12 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
7.8%
7/90 • Number of events 10 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
15.5%
13/84 • Number of events 21 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
Gastrointestinal disorders
nausea
|
54.4%
49/90 • Number of events 64 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
23.8%
20/84 • Number of events 24 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
General disorders
night sweats
|
5.6%
5/90 • Number of events 6 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
6.0%
5/84 • Number of events 6 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
Gastrointestinal disorders
other GI
|
27.8%
25/90 • Number of events 45 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
27.4%
23/84 • Number of events 29 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
Infections and infestations
URI/cold symptoms
|
22.2%
20/90 • Number of events 23 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
16.7%
14/84 • Number of events 17 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
|
Gastrointestinal disorders
vomiting
|
23.3%
21/90 • Number of events 27 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
10.7%
9/84 • Number of events 10 • Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place