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

Completed · Phase 1/Phase 2

Conditions studied: Smoking, Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT00129246

Run by

Yale University

People needed

40

Starts

2004-12-01

Expected to finish

2005-12-01

Last updated by the study team

2020-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Yale University School of Medicine Substance Abuse Treatment Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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