Trial Outcomes & Findings for Human Laboratory Study of Varenicline for Alcohol Use Disorder (NCT NCT03035708)
NCT ID: NCT03035708
Last Updated: 2019-10-23
Results Overview
The primary outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue. The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Study Week 3
Results posted on
2019-10-23
Participant Flow
Participant milestones
| Measure |
Varenicline
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
19
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Human Laboratory Study of Varenicline for Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Varenicline
n=23 Participants
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=24 Participants
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Drinks per day
|
6.9 drinks/day
STANDARD_DEVIATION 2.4 • n=5 Participants
|
7.6 drinks/day
STANDARD_DEVIATION 2.7 • n=7 Participants
|
7.3 drinks/day
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Drinking per drinking day
|
8.5 drinks/drinking day
STANDARD_DEVIATION 4.1 • n=5 Participants
|
9.3 drinks/drinking day
STANDARD_DEVIATION 5.2 • n=7 Participants
|
8.9 drinks/drinking day
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Percent days abstinent
|
15.1 percent days abstinent
STANDARD_DEVIATION 16.9 • n=5 Participants
|
11.8 percent days abstinent
STANDARD_DEVIATION 15.9 • n=7 Participants
|
13.4 percent days abstinent
STANDARD_DEVIATION 16.3 • n=5 Participants
|
|
Percent heavy drinking days
|
66.3 percent heavy drinking days
STANDARD_DEVIATION 26.5 • n=5 Participants
|
71.9 percent heavy drinking days
STANDARD_DEVIATION 24.3 • n=7 Participants
|
69.2 percent heavy drinking days
STANDARD_DEVIATION 25.3 • n=5 Participants
|
|
Penn Alcohol Craving Scale (PACS) score
|
18.0 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
|
17.8 units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Current smoker (past week)
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Week 3Population: mITT
The primary outcome is cue-elicited alcohol craving, operationalized as the difference in Visual Analog Scale (VAS) craving for alcohol when exposed to an alcohol cue minus the VAS craving for alcohol when exposed to a water cue. The VAS has a minimum value of 0 and maximum value of 20; higher scores indicate more craving (a worse outcome).
Outcome measures
| Measure |
Varenicline
n=22 Participants
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=22 Participants
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Cue-elicited Craving
|
2.1 units on a scale
Standard Error 0.4
|
2.2 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Weeks 3-6Population: mITT
The percentage of heavy drinking days during the last month of treatment (weeks 3-6). A heavy drinking day is defined as 4 or more drinks on a single day for females and 5 or more drinks on a single day for males.
Outcome measures
| Measure |
Varenicline
n=22 Participants
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=23 Participants
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Percent Heavy Drinking Days
|
30.7 percentage of heavy drinking days
Standard Error 4.9
|
21.0 percentage of heavy drinking days
Standard Error 5.0
|
SECONDARY outcome
Timeframe: Weeks 3-6Population: mITT
The percentage of subjects abstinent from alcohol during the last month of treatment (weeks 3-6).
Outcome measures
| Measure |
Varenicline
n=22 Participants
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=23 Participants
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
The Percentage of Subjects Abstinent During the Last Month of Treatment (Weeks 3-6).
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Weeks 3-6Population: mITT
The number of cigarettes smoked per week during the last month of treatment (weeks 3-6) computed only among participants who were smokers at baseline (varenicline n=11; placebo n=11). Note: cigarettes smoked per week outcome data was missing for two of the varenicline participants resulting in n=9 available for analysis.
Outcome measures
| Measure |
Varenicline
n=9 Participants
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=11 Participants
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Cigarettes Smoked Per Week
|
47.0 cigarettes per week
Standard Error 7.7
|
64.0 cigarettes per week
Standard Error 7.6
|
SECONDARY outcome
Timeframe: Study Weeks 3, 4, 5, 6 (assessed weekly during this period)Population: mITT
Penn Alcohol Craving Scale (higher numbers are indicative of more craving for alcohol); min = 0, max = 30. The measure was assessed at Study Weeks 3, 4, 5, and 6. The reported outcome is the adjusted mean total score across weeks 3-6.
Outcome measures
| Measure |
Varenicline
n=22 Participants
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=23 Participants
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Penn Alcohol Craving Scale
|
10.8 units on a scale
Standard Error 1.1
|
10.9 units on a scale
Standard Error 1.1
|
Adverse Events
Varenicline
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Varenicline
n=23 participants at risk
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=24 participants at risk
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
0.00%
0/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
Other adverse events
| Measure |
Varenicline
n=23 participants at risk
1 mg BID (2 capsules BID)
Varenicline: 1 mg BID
|
Placebo
n=24 participants at risk
1 mg BID (2 capsules BID)
Placebo oral capsule: 1 mg BID
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
43.5%
10/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
16.7%
4/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Psychiatric disorders
Abnormal Dreams
|
30.4%
7/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
20.8%
5/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
General disorders
Nasopharyngitis
|
4.3%
1/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
25.0%
6/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Renal and urinary disorders
Bright Urine
|
13.0%
3/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
4.2%
1/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
8.3%
2/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Psychiatric disorders
Anxiety
|
8.7%
2/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
0.00%
0/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Reproductive system and breast disorders
Gynecological bleeding
|
4.3%
1/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
8.3%
2/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
General disorders
Headache
|
8.7%
2/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
4.2%
1/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
4.2%
1/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
|
Eye disorders
Blurred Vision
|
8.7%
2/23 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
4.2%
1/24 • Weeks 1 to 6
Definitions and descriptions are consistent with those in clinicaltrials.gov.
|
Additional Information
Health Scientist Administrator
National Institute on Alcohol Abuse and Alcoholism
Phone: 301-443-0788
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place