Trial Outcomes & Findings for Varenicline Treatment for Cannabis Use Disorder (NCT NCT02892110)
NCT ID: NCT02892110
Last Updated: 2019-12-03
Results Overview
For this outcome, the negative affect subscale items of The Cannabis Withdrawal Scale (items 5 \["I felt nervous\], 6 \["I had some angry outbursts"\], 7 \["I had mood swings"\], 8 \["I felt depressed"\], 9 \["I was easily irritated"\], 15 \["Life seemed an uphill struggle"\], 18 \["I felt physically tense"\], restlessness (item 11, "I felt restless), and/or urge to smoke (items 1 and 10, "The only thing I could think about was smoking some cannabis" and "I had been imagining being stoned") were averaged at Weeks 4, 5, and 6 and for an overall 4-6 week value, with minimum score of the subscale being 0 and maximum score being 100 (higher score indicating worse outcome).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
72 participants
Primary outcome timeframe
3 weeks (Week 4-6 of active treatment period)
Results posted on
2019-12-03
Participant Flow
Participant milestones
| Measure |
Varenicline
2 mg daily
Varenicline: 2 mg daily
|
Placebo
2 mg daily
Placebo: 2 mg daily
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
37
|
|
Overall Study
COMPLETED
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varenicline Treatment for Cannabis Use Disorder
Baseline characteristics by cohort
| Measure |
Varenicline
n=35 Participants
2 mg daily
Varenicline: 2 mg daily
|
Placebo
n=37 Participants
2 mg daily
Placebo: 2 mg daily
|
Total
n=72 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
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 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
|
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
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
42 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks (Week 4-6 of active treatment period)For this outcome, the negative affect subscale items of The Cannabis Withdrawal Scale (items 5 \["I felt nervous\], 6 \["I had some angry outbursts"\], 7 \["I had mood swings"\], 8 \["I felt depressed"\], 9 \["I was easily irritated"\], 15 \["Life seemed an uphill struggle"\], 18 \["I felt physically tense"\], restlessness (item 11, "I felt restless), and/or urge to smoke (items 1 and 10, "The only thing I could think about was smoking some cannabis" and "I had been imagining being stoned") were averaged at Weeks 4, 5, and 6 and for an overall 4-6 week value, with minimum score of the subscale being 0 and maximum score being 100 (higher score indicating worse outcome).
Outcome measures
| Measure |
Varenicline
n=22 Participants
2 mg daily
Varenicline: 2 mg daily
|
Placebo
n=25 Participants
2 mg daily
Placebo: 2 mg daily
|
|---|---|---|
|
Cannabis Withdrawal Symptoms During Active Treatment
Overall Week 4-6 average
|
2.23 score on a scale
Standard Deviation 4.65
|
3.94 score on a scale
Standard Deviation 6.23
|
|
Cannabis Withdrawal Symptoms During Active Treatment
Week 4
|
2.59 score on a scale
Standard Deviation 6.73
|
4.07 score on a scale
Standard Deviation 5.81
|
|
Cannabis Withdrawal Symptoms During Active Treatment
Week 5
|
2.15 score on a scale
Standard Deviation 4.84
|
4.27 score on a scale
Standard Deviation 7.11
|
|
Cannabis Withdrawal Symptoms During Active Treatment
Week 6
|
1.96 score on a scale
Standard Deviation 4.65
|
3.47 score on a scale
Standard Deviation 6.07
|
SECONDARY outcome
Timeframe: 3 weeks (Week 4-6 of active treatment period)Self reported abstinence from Timeline Followback, verified by urine cannabinoid measures
Outcome measures
| Measure |
Varenicline
n=22 Participants
2 mg daily
Varenicline: 2 mg daily
|
Placebo
n=25 Participants
2 mg daily
Placebo: 2 mg daily
|
|---|---|---|
|
Number of Participants With Cannabis Abstinence
Week 4
|
5 Participants
|
3 Participants
|
|
Number of Participants With Cannabis Abstinence
Week 5
|
4 Participants
|
2 Participants
|
|
Number of Participants With Cannabis Abstinence
Week 6
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 weeks (Week 4-6 of active treatment period)Cannabis use sessions per day measured by Timeline Followback (self-report) at twice weekly visits during Weeks 4, 5 and 6 of the active treatment phase.
Outcome measures
| Measure |
Varenicline
n=22 Participants
2 mg daily
Varenicline: 2 mg daily
|
Placebo
n=25 Participants
2 mg daily
Placebo: 2 mg daily
|
|---|---|---|
|
Cannabis Use Quantity
Week 4
|
0.93 sessions per day
Interval 0.54 to 1.33
|
1.33 sessions per day
Interval 0.96 to 1.7
|
|
Cannabis Use Quantity
Week 5
|
0.89 sessions per day
Interval 0.5 to 1.28
|
1.19 sessions per day
Interval 0.82 to 1.56
|
|
Cannabis Use Quantity
Week 6
|
0.89 sessions per day
Interval 0.5 to 1.29
|
1.21 sessions per day
Interval 0.84 to 1.58
|
Adverse Events
Varenicline
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=35 participants at risk
2 mg daily
Varenicline: 2 mg daily
|
Placebo
n=37 participants at risk
2 mg daily
Placebo: 2 mg daily
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
0.00%
0/37 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
Other adverse events
| Measure |
Varenicline
n=35 participants at risk
2 mg daily
Varenicline: 2 mg daily
|
Placebo
n=37 participants at risk
2 mg daily
Placebo: 2 mg daily
|
|---|---|---|
|
General disorders
Allergies
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
10.8%
4/37 • Number of events 4 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.4%
4/35 • Number of events 4 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
13.5%
5/37 • Number of events 5 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
General disorders
Dream disturbance
|
42.9%
15/35 • Number of events 15 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
18.9%
7/37 • Number of events 8 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Gastrointestinal disorders
Fatigue
|
11.4%
4/35 • Number of events 4 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
General disorders
Headache
|
25.7%
9/35 • Number of events 11 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
32.4%
12/37 • Number of events 15 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
General disorders
Insomnia
|
22.9%
8/35 • Number of events 8 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
24.3%
9/37 • Number of events 10 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
General disorders
Irritability
|
5.7%
2/35 • Number of events 2 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
21.6%
8/37 • Number of events 9 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
2.9%
1/35 • Number of events 1 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
10.8%
4/37 • Number of events 4 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Gastrointestinal disorders
Nausea
|
45.7%
16/35 • Number of events 19 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
24.3%
9/37 • Number of events 10 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
URI/cold symptoms
|
20.0%
7/35 • Number of events 8 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
18.9%
7/37 • Number of events 11 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
17.1%
6/35 • Number of events 7 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
13.5%
5/37 • Number of events 7 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
Gastrointestinal disorders
Other GI
|
22.9%
8/35 • Number of events 9 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
24.3%
9/37 • Number of events 10 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
|
General disorders
Dizziness
|
8.6%
3/35 • Number of events 4 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
2.7%
1/37 • Number of events 1 • Adverse event data were collected from time of consent through last study visit (approximately 8 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place