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Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain

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ClinicalTrials.gov Identifier: NCT00129246
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : February 5, 2013
Last Update Posted : December 3, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Smoking
Nicotine Dependence
Interventions Drug: Naltrexone
Drug: Bupropion
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bupropion Only Naltrexone +Bupropion
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Bupropion Only Naltrexone +Bupropion Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
42.3  (12.3) 43.0  (11.2) 42.7  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
14
  70.0%
14
  70.0%
28
  70.0%
Male
6
  30.0%
6
  30.0%
12
  30.0%
1.Primary Outcome
Title Smoking Cessation
Hide Description Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis
Arm/Group Title Bupropion Only Naltrexone +Bupropion
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
6 6
2.Primary Outcome
Title Point Prevalence Abstinence
Hide Description Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis
Arm/Group Title Bupropion Only Naltrexone +Bupropion
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
8 8
3.Primary Outcome
Title Weight Gain
Hide Description Weight gain for for the entire sample in pounds at 6 weeks.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis
Arm/Group Title Bupropion Only Naltrexone +Bupropion
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: lbs
1.25  (2.90) 0.28  (3.88)
4.Secondary Outcome
Title Weight Gain Abstinent Participants
Hide Description Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol analysis
Arm/Group Title Bupropion Only Naltrexone +Bupropion
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: lbs
3.17  (2.04) 1.67  (3.17)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion Only Naltrexone +Bupropion
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Bupropion Only Naltrexone +Bupropion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Bupropion Only Naltrexone +Bupropion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bupropion Only Naltrexone +Bupropion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      9/20 (45.00%)    
Ear and labyrinth disorders     
Ringing in ears  0/20 (0.00%)  0 1/20 (5.00%)  1
Gastrointestinal disorders     
Nausea  1/20 (5.00%)  1 5/20 (25.00%)  5
Vomiting  1/20 (5.00%)  1 1/20 (5.00%)  1
Diarrhea  1/20 (5.00%)  1 0/20 (0.00%)  0
Constipation  0/20 (0.00%)  0 2/20 (10.00%)  2
General disorders     
Fatigue  0/20 (0.00%)  0 1/20 (5.00%)  1
Dry mouth  4/20 (20.00%)  4 4/20 (20.00%)  4
Nervous system disorders     
Headache  0/20 (0.00%)  0 2/20 (10.00%)  2
Dizziness  0/20 (0.00%)  0 1/20 (5.00%)  1
Psychiatric disorders     
Nervousness/anxiety  2/20 (10.00%)  2 4/20 (20.00%)  4
Insomnia  5/20 (25.00%)  5 3/20 (15.00%)  3
Irritability  2/20 (10.00%)  2 2/20 (10.00%)  2
Skin and subcutaneous tissue disorders     
Pruritus  2/20 (10.00%)  2 0/20 (0.00%)  0
Alopecia  0/20 (0.00%)  0 1/20 (5.00%)  1
Sweating  1/20 (5.00%)  1 2/20 (10.00%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Benjamin A. Toll, PhD
Organization: Associate Professor of Psychiatry and Program Director, Smoking Cessation Service at Smilow Cancer Hospital at Yale-New Haven
Phone: (203) 974 5767
EMail: benjamin.toll@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00129246    
Other Study ID Numbers: NIAAAOMA15632-B
P50AA015632 ( U.S. NIH Grant/Contract )
NIH Grant 9 P50-AA15632
First Submitted: August 9, 2005
First Posted: August 11, 2005
Results First Submitted: January 2, 2013
Results First Posted: February 5, 2013
Last Update Posted: December 3, 2020