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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Bupropion; Naltrexone

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)