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: * effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and * compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, United States
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
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