Status:
COMPLETED
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Smoking
Nicotine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
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 conducte...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00129246
Start Date
December 1 2004
End Date
December 1 2005
Last Update
December 3 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511