Trial Outcomes & Findings for Varenicline to Reduce Alcohol Consumption in Heavy Drinkers (NCT NCT00695500)
NCT ID: NCT00695500
Last Updated: 2016-08-15
Results Overview
Peak Breath Alcohol Concentration during IV alcohol self-administration
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
2.5 hr session following 3 weeks of treatment
Results posted on
2016-08-15
Participant Flow
Four participants were enrolled (consented) but withdrew prior to group assignment.
Participant milestones
| Measure |
Varenicline
Varenicline tablets, 2 mg per day for 3 weeks
|
Placebo
Placebo tablets, 0 mg per day for 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varenicline to Reduce Alcohol Consumption in Heavy Drinkers
Baseline characteristics by cohort
| Measure |
Varenicline
n=24 Participants
Varenicline tablets, 2 mg per day for 3 weeks
|
Placebo
n=22 Participants
Placebo tablets, 0 mg per day for 3 weeks
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
44 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2.5 hr session following 3 weeks of treatmentPopulation: sample that completed the assessment
Peak Breath Alcohol Concentration during IV alcohol self-administration
Outcome measures
| Measure |
Varenicline
n=16 Participants
Varenicline tablets, 2 mg per day for 3 weeks
|
Placebo
n=12 Participants
Placebo tablets, 0 mg per day for 3 weeks
|
|---|---|---|
|
Alcohol Consumption
|
92.0 mg/%
Standard Error 11.6
|
77.3 mg/%
Standard Error 13.5
|
SECONDARY outcome
Timeframe: 2.5 hr session following 3 weeks of treatmentPopulation: sample that completed the assessment
Peak Alcohol Urge Questionnaire Score during IV alcohol self-administration. Scale: Alcohol Urge Questionnaire. Contains 8 items, each item scored on a likert scale from 1 to 7. Range: Total scores range between 8 and 64. Higher scores indicate higher urges for alcohol.
Outcome measures
| Measure |
Varenicline
n=16 Participants
Varenicline tablets, 2 mg per day for 3 weeks
|
Placebo
n=12 Participants
Placebo tablets, 0 mg per day for 3 weeks
|
|---|---|---|
|
Alcohol Urges
|
23.65 Units on a scale
Standard Error 2.74
|
26.82 Units on a scale
Standard Error 3.70
|
OTHER_PRE_SPECIFIED outcome
Timeframe: fMRI session following 2 weeks of treatmentPopulation: sample that completed the assessment
Percent BOLD signal change during Alcohol Food Incentive Delay Task (Alcohol - Neutral)
Outcome measures
| Measure |
Varenicline
n=16 Participants
Varenicline tablets, 2 mg per day for 3 weeks
|
Placebo
n=12 Participants
Placebo tablets, 0 mg per day for 3 weeks
|
|---|---|---|
|
BOLD Response to Alcohol Cue
|
-0.021 Percent Signal Change
Standard Error 0.051
|
0.194 Percent Signal Change
Standard Error 0.080
|
Adverse Events
Varenicline
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Varenicline
n=24 participants at risk
Varenicline tablets, 2 mg per day for 3 weeks
|
Placebo
n=22 participants at risk
Placebo tablets, 0 mg per day for 3 weeks
|
|---|---|---|
|
Cardiac disorders
Chest pain - cardiac
|
16.7%
4/24 • 6 weeks
|
4.5%
1/22 • 6 weeks
|
|
Cardiac disorders
Palpitations
|
8.3%
2/24 • 6 weeks
|
18.2%
4/22 • 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
29.2%
7/24 • 6 weeks
|
27.3%
6/22 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
6/24 • 6 weeks
|
13.6%
3/22 • 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
41.7%
10/24 • 6 weeks
|
22.7%
5/22 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
58.3%
14/24 • 6 weeks
|
27.3%
6/22 • 6 weeks
|
|
Gastrointestinal disorders
Stomach pain
|
25.0%
6/24 • 6 weeks
|
18.2%
4/22 • 6 weeks
|
|
General disorders
Irritability
|
25.0%
6/24 • 6 weeks
|
18.2%
4/22 • 6 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
6/24 • 6 weeks
|
0.00%
0/22 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
45.8%
11/24 • 6 weeks
|
31.8%
7/22 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.8%
5/24 • 6 weeks
|
27.3%
6/22 • 6 weeks
|
|
Nervous system disorders
Headache
|
45.8%
11/24 • 6 weeks
|
36.4%
8/22 • 6 weeks
|
|
Nervous system disorders
Lethargy
|
54.2%
13/24 • 6 weeks
|
50.0%
11/22 • 6 weeks
|
|
Nervous system disorders
Memory impairment
|
45.8%
11/24 • 6 weeks
|
40.9%
9/22 • 6 weeks
|
|
Nervous system disorders
Somnolence
|
29.2%
7/24 • 6 weeks
|
27.3%
6/22 • 6 weeks
|
|
Psychiatric disorders
Agitation
|
4.2%
1/24 • 6 weeks
|
13.6%
3/22 • 6 weeks
|
|
Psychiatric disorders
Anxiety
|
33.3%
8/24 • 6 weeks
|
31.8%
7/22 • 6 weeks
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
70.8%
17/24 • 6 weeks
|
54.5%
12/22 • 6 weeks
|
|
Reproductive system and breast disorders
Uterine pain
|
12.5%
3/24 • 6 weeks
|
4.5%
1/22 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.8%
11/24 • 6 weeks
|
36.4%
8/22 • 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
2/24 • 6 weeks
|
9.1%
2/22 • 6 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
4/24 • 6 weeks
|
9.1%
2/22 • 6 weeks
|
Additional Information
Ramchandani, Vijay
National Institute on Alcohol Abuse and Alcoholism
Phone: +1 301 402 8527
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place