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

Phase 1

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Ages 18 and older
Willingness and ability to give written consent
Smoking at least 10 cigarettes per day for at least 1 year
Baseline expired carbon-monoxide level of at least 10 ppm
Weigh at least 100 lbs.
English-speaking
One person per household
At least 1 prior quit attempt
Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants.

Exclusion Criteria

Pregnant or nursing women or women attempting to conceive
Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension
Current alcohol dependence
Current use of opiates, and/or a urine toxicology screen positive for opiates
Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
Evidence of significant hepatocellular injury as evidenced by AST or ALT >3 x normal or elevated bilirubin
History of cirrhosis
Body mass index (BMI) greater than 35
History of anorexia nervosa or bulimia
Current major depression
Currently taking Toprol-XL (or metoprolol succinate)
History of seizure disorder or serious brain injury
Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion
Previous hypersensitivity to bupropion
Patients requiring concomitant therapy with any psychotropic drug
Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)

Arm && Interventions

Group	Intervention	Description
Naltrexone +Bupropion	Naltrexone	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).
Bupropion only	Bupropion	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).
Naltrexone +Bupropion	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).

Primary Outcome Measures

Name	Time	Method
Weight Gain	Week 6	Weight gain for for the entire sample in pounds at 6 weeks.
Point Prevalence Abstinence	Week 6	Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Smoking Cessation	Week 6	Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.