Trial Outcomes & Findings for The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse (NCT NCT00773422)
NCT ID: NCT00773422
Last Updated: 2018-04-23
Results Overview
Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
day 8
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
Naltrexone + Varenicline
naltrexone (25mg) + varenicline (2mg)
naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Varenicline
varenicline 2mg
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Placebo
placebo control
placebo: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Naltrexone and Varenicline on Alcohol-Mediated Smoking Lapse
Baseline characteristics by cohort
| Measure |
Naltrexone + Varenicline
n=11 Participants
naltrexone (25mg) + varenicline (2mg)
naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Varenicline
n=9 Participants
varenicline 2mg
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Placebo
n=10 Participants
placebo control
placebo: placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.91 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
37.67 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
33.20 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
33.33 years
STANDARD_DEVIATION 10.71 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: day 8Time to smoking during the smoking delay task. Smoking delay task occurred on day 8 of the study. Range of time delay is 0 minutes to 50 minutes.
Outcome measures
| Measure |
Naltrexone + Varenicline
n=11 Participants
naltrexone (25mg) + varenicline (2mg)
naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Varenicline
n=9 Participants
varenicline 2mg
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Placebo
n=10 Participants
placebo control
placebo: placebo
|
|---|---|---|---|
|
Latency to Initiate Ad-lib Smoking Session
|
28.134 minutes
Standard Error 5.328
|
45.861 minutes
Standard Error 6.238
|
21.737 minutes
Standard Error 6.043
|
SECONDARY outcome
Timeframe: day 8Number of cigarettes smoked during the ad libitum phase of the smoking delay task. Task occurred on day 8 of the study.
Outcome measures
| Measure |
Naltrexone + Varenicline
n=11 Participants
naltrexone (25mg) + varenicline (2mg)
naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Varenicline
n=9 Participants
varenicline 2mg
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Placebo
n=10 Participants
placebo control
placebo: placebo
|
|---|---|---|---|
|
Number of Cigarettes Smoked During the Ad-lib Period
|
1.283 cigarettes
Standard Error 0.283
|
0.959 cigarettes
Standard Error 0.331
|
2.23 cigarettes
Standard Error 0.331
|
Adverse Events
Naltrexone + Varenicline
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Varenicline
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naltrexone + Varenicline
n=11 participants at risk
naltrexone (25mg) + varenicline (2mg)
naltrexone: 25 mg/day, with 1-week lead-in medication period. The starting dose is 0 mg/day for days 1-3, followed by 12.5mg/day for day 4, followed by 25mg/day for days 5-7, plus during the laboratory session (day 8).
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Varenicline
n=9 participants at risk
varenicline 2mg
varenicline: 2mg/day, with 1-week lead-in medication period. The starting dose is 0.5mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5, followed by 1.0 mg twice daily for days 6-7, plus during the laboratory session (day 8).
|
Placebo
n=10 participants at risk
placebo control
placebo: placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea/vomiting
|
18.2%
2/11
|
22.2%
2/9
|
10.0%
1/10
|
|
General disorders
Headache
|
0.00%
0/11
|
11.1%
1/9
|
40.0%
4/10
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11
|
11.1%
1/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Flatulence
|
9.1%
1/11
|
11.1%
1/9
|
10.0%
1/10
|
|
General disorders
Abnormal dreams
|
9.1%
1/11
|
0.00%
0/9
|
10.0%
1/10
|
|
General disorders
Abdominal pain
|
18.2%
2/11
|
33.3%
3/9
|
10.0%
1/10
|
|
General disorders
Erratic Behavior
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11
|
44.4%
4/9
|
0.00%
0/10
|
|
General disorders
Dry mouth
|
0.00%
0/11
|
22.2%
2/9
|
10.0%
1/10
|
|
General disorders
Insomnia
|
9.1%
1/11
|
11.1%
1/9
|
0.00%
0/10
|
|
General disorders
Difficulty Breathing
|
0.00%
0/11
|
11.1%
1/9
|
10.0%
1/10
|
|
General disorders
Tight chest
|
9.1%
1/11
|
11.1%
1/9
|
10.0%
1/10
|
|
Cardiac disorders
Fast heartbeat
|
0.00%
0/11
|
11.1%
1/9
|
0.00%
0/10
|
|
General disorders
Suicidal Thoughts
|
0.00%
0/11
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Depressed Mood
|
0.00%
0/11
|
11.1%
1/9
|
0.00%
0/10
|
|
General disorders
Appetite change
|
18.2%
2/11
|
0.00%
0/9
|
20.0%
2/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place