Clinical trial NCT00129246: Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Official title: Naltrexone & Bupropion to Stop Smoking With Less Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking
Nicotine Dependence
Keywords: Tobacco
Smoking
Weight
Weight perception
Naltrexone
Bupropion
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Smoking Cessation
timeFrame: Week 6
measure: Point Prevalence Abstinence
timeFrame: Week 6
measure: Weight Gain
timeFrame: Week 6
Secondary outcomes:
measure: Weight Gain Abstinent Participants
timeFrame: Week 6
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine Substance Abuse Treatment Unit
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine, Department of Psychiatry
name: Benjamin Toll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toll BA, Leary V, Wu R, Salovey P, Meandzija B, O'Malley SS. A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain. Addict Behav. 2008 Jan;33(1):173-9. doi: 10.1016/j.addbeh.2007.05.012. Epub 2007 Jun 2.