Trial Outcomes & Findings for Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain (NCT NCT00129246)
NCT ID: NCT00129246
Last Updated: 2020-12-03
Results Overview
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Week 6
Results posted on
2020-12-03
Participant Flow
Participant milestones
| Measure |
Bupropion Only
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Baseline characteristics by cohort
| Measure |
Bupropion Only
n=20 Participants
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
n=20 Participants
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
42.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Per protocol analysis
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Outcome measures
| Measure |
Bupropion Only
n=20 Participants
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
n=20 Participants
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
|---|---|---|
|
Smoking Cessation
|
6 participants
|
6 participants
|
PRIMARY outcome
Timeframe: Week 6Population: Per protocol analysis
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Outcome measures
| Measure |
Bupropion Only
n=20 Participants
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
n=20 Participants
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
|---|---|---|
|
Point Prevalence Abstinence
|
8 participants
|
8 participants
|
PRIMARY outcome
Timeframe: Week 6Population: Per protocol analysis
Weight gain for for the entire sample in pounds at 6 weeks.
Outcome measures
| Measure |
Bupropion Only
n=20 Participants
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
n=20 Participants
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
|---|---|---|
|
Weight Gain
|
1.25 lbs
Standard Deviation 2.90
|
0.28 lbs
Standard Deviation 3.88
|
SECONDARY outcome
Timeframe: Week 6Population: Per protocol analysis
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
Outcome measures
| Measure |
Bupropion Only
n=6 Participants
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
n=6 Participants
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
|---|---|---|
|
Weight Gain Abstinent Participants
|
3.17 lbs
Standard Deviation 2.04
|
1.67 lbs
Standard Deviation 3.17
|
Adverse Events
Bupropion Only
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Naltrexone +Bupropion
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupropion Only
n=20 participants at risk
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Naltrexone +Bupropion
n=20 participants at risk
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1
|
25.0%
5/20 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Nervousness/anxiety
|
10.0%
2/20 • Number of events 2
|
20.0%
4/20 • Number of events 4
|
|
Psychiatric disorders
Insomnia
|
25.0%
5/20 • Number of events 5
|
15.0%
3/20 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • Number of events 2
|
0.00%
0/20
|
|
General disorders
Dry mouth
|
20.0%
4/20 • Number of events 4
|
20.0%
4/20 • Number of events 4
|
|
Psychiatric disorders
Irritability
|
10.0%
2/20 • Number of events 2
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
Ear and labyrinth disorders
Ringing in ears
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sweating
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
Additional Information
Benjamin A. Toll, PhD
Associate Professor of Psychiatry and Program Director, Smoking Cessation Service at Smilow Cancer Hospital at Yale-New Haven
Phone: (203) 974 5767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place