Trial Outcomes & Findings for Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment (NCT NCT00938886)
NCT ID: NCT00938886
Last Updated: 2017-05-15
Results Overview
Defined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Across the 6 months following smoking quit date
Results posted on
2017-05-15
Participant Flow
Participants were recruited from Providence, RI and the surrounding community through bulletin board, radio, internet, newspaper, and public transportation advertisements.
Participant milestones
| Measure |
Naltrexone
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
Attended 1 Counseling Session
|
70
|
70
|
|
Overall Study
COMPLETED
|
68
|
65
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
Naltrexone
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Naltrexone for At-Risk and Problem Drinking in Smoking Cessation Treatment
Baseline characteristics by cohort
| Measure |
Naltrexone
n=75 Participants
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
n=75 Participants
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Current Alcohol Dependence
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
|
5.3 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 2.3 • n=7 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Across the 6 months following smoking quit dateDefined for women as percent of days drinking 4 or more drinks in a day. For men, percent of days drinking 5 or more drinks in a day
Outcome measures
| Measure |
Naltrexone
n=68 Participants
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
n=65 Participants
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
|---|---|---|
|
Percent Heavy Drinking Days
|
11.1 percentage of days
Standard Deviation 13.1
|
11.4 percentage of days
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: 26 weeks after target quit smoking dateSelf-report abstinence from smoking over the past 7 days biochemically confirmed with carbon monoxide and saliva cotinine.
Outcome measures
| Measure |
Naltrexone
n=75 Participants
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
n=75 Participants
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
|---|---|---|
|
7-day Point Prevalence Smoking Abstinence
|
9 Participants
|
9 Participants
|
Adverse Events
Naltrexone
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 36 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Naltrexone
n=75 participants at risk
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
n=75 participants at risk
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
|---|---|---|
|
General disorders
Appendectomy
|
0.00%
0/75 • 10 weeks
|
1.3%
1/75 • Number of events 1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Back Surgery
|
0.00%
0/75 • 10 weeks
|
1.3%
1/75 • Number of events 1 • 10 weeks
|
Other adverse events
| Measure |
Naltrexone
n=75 participants at risk
50 mg daily naltrexone for 10 weeks
Naltrexone: Daily 50 mg naltrexone
|
Placebo
n=75 participants at risk
Daily matched placebo pill
Placebo: Matched naltrexone placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.7%
8/75 • Number of events 8 • 10 weeks
|
5.3%
4/75 • Number of events 4 • 10 weeks
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
7/75 • Number of events 7 • 10 weeks
|
9.3%
7/75 • Number of events 7 • 10 weeks
|
|
Gastrointestinal disorders
Adbominal pain
|
6.7%
5/75 • Number of events 5 • 10 weeks
|
9.3%
7/75 • Number of events 7 • 10 weeks
|
|
Gastrointestinal disorders
Decreased appetite
|
6.7%
5/75 • Number of events 5 • 10 weeks
|
4.0%
3/75 • Number of events 3 • 10 weeks
|
|
General disorders
Headache
|
5.3%
4/75 • Number of events 4 • 10 weeks
|
13.3%
10/75 • Number of events 10 • 10 weeks
|
|
General disorders
Dizziness
|
4.0%
3/75 • Number of events 3 • 10 weeks
|
5.3%
4/75 • Number of events 4 • 10 weeks
|
|
General disorders
Fatigue
|
6.7%
5/75 • Number of events 5 • 10 weeks
|
9.3%
7/75 • Number of events 7 • 10 weeks
|
|
Psychiatric disorders
Anxiety
|
10.7%
8/75 • Number of events 8 • 10 weeks
|
14.7%
11/75 • Number of events 11 • 10 weeks
|
|
General disorders
Insomnia
|
14.7%
11/75 • Number of events 11 • 10 weeks
|
25.3%
19/75 • Number of events 19 • 10 weeks
|
|
General disorders
Somnolence
|
12.0%
9/75 • Number of events 9 • 10 weeks
|
21.3%
16/75 • Number of events 16 • 10 weeks
|
|
Psychiatric disorders
Depression
|
12.0%
9/75 • Number of events 9 • 10 weeks
|
9.3%
7/75 • Number of events 7 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
2.7%
2/75 • Number of events 2 • 10 weeks
|
6.7%
5/75 • Number of events 5 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place