Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Smoking, Nicotine Dependence
About this trial
This is an interventional treatment trial for Smoking focused on measuring Tobacco, Smoking, Weight, Weight perception, Naltrexone, Bupropion
Eligibility Criteria
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)
Sites / Locations
- Yale University School of Medicine Substance Abuse Treatment Unit
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Bupropion only
Naltrexone +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).
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).