A Phase 1/2 interventional study of Naltrexone and Bupropion in Smoking and Nicotine Dependence, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-03.
Sponsored by Yale University · Phase 1/2, Interventional, and Treatment
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:
405 studies on the registry are indexed under Weight Gain; 52 are open to participants now.
This study's enrollment of 40 is below the median of 83 across 324 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: 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).
Drug: Naltrexone · Drug: Bupropion
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.
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
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Time frame: Week 6
Point Prevalence Abstinence
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Time frame: Week 6
Weight Gain
Weight gain for for the entire sample in pounds at 6 weeks.
Time frame: Week 6
Weight Gain Abstinent Participants
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
Time frame: Week 6
| Milestone | Bupropion Only | Naltrexone +Bupropion |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
| participants | Bupropion Only | Naltrexone +Bupropion |
|---|---|---|
| Smoking Cessation | 6 | 6 |
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
| participants | Bupropion Only | Naltrexone +Bupropion |
|---|---|---|
| Point Prevalence Abstinence | 8 | 8 |
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
| lbs | Bupropion Only | Naltrexone +Bupropion |
|---|---|---|
| Weight Gain Abstinent Participants | 3.17 ± 2.04 | 1.67 ± 3.17 |
Weight gain for for the entire sample in pounds at 6 weeks.
| lbs | Bupropion Only | Naltrexone +Bupropion |
|---|---|---|
| Weight Gain | 1.25 ± 2.90 | 0.28 ± 3.88 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bupropion Only | — | 0/20 (0%) | 8/20 (40%) |
| Naltrexone +Bupropion | — | 0/20 (0%) | 9/20 (45%) |
| Event | Bupropion Only | Naltrexone +Bupropion |
|---|---|---|
| NauseaGastrointestinal disorders | 1/20 | 5/20 |
| InsomniaPsychiatric disorders | 5/20 | 3/20 |
| Nervousness/anxietyPsychiatric disorders | 2/20 | 4/20 |
| Dry mouthGeneral disorders | 4/20 | 4/20 |
| HeadacheNervous system disorders | 0/20 | 2/20 |
| PruritusSkin and subcutaneous tissue disorders | 2/20 | 0/20 |
| IrritabilityPsychiatric disorders | 2/20 | 2/20 |
| ConstipationGastrointestinal disorders | 0/20 | 2/20 |
| SweatingSkin and subcutaneous tissue disorders | 1/20 | 2/20 |
| VomitingGastrointestinal disorders | 1/20 | 1/20 |
| Age, Continuous(years) | Bupropion Only | Naltrexone +Bupropion | Total |
|---|---|---|---|
| Mean | 42.3 ± 12.3 | 43.0 ± 11.2 | 42.7 ± 11.6 |
| Sex: Female, Male(Participants) | Bupropion Only | Naltrexone +Bupropion | Total |
|---|---|---|---|
| Female | 14 | 14 | 28 |
| Male | 6 | 6 | 12 |
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yale University