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Completed

NCT Number: NCT00129246

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

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.

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Key information

Conditions

Smoking Behavior Body Weight Chemically-Induced Disorders Mental Disorders Nicotine Dependence Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Yale University School of Medicine Substance Abuse Treatment Unit

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Naltrexone

Drug

Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.

bupropion

Drug

Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.

Primary outcomes

  1. Smoking Cessation

    Time frame: Week 6

    Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.

  2. Point Prevalence Abstinence

    Time frame: Week 6

    Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.

  3. Weight Gain

    Time frame: Week 6

    Weight gain for for the entire sample in pounds at 6 weeks.

Secondary outcomes

  1. Weight Gain Abstinent Participants

    Time frame: Week 6

    Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Naltrexone & Bupropion to Stop Smoking With Less Weight Gain

Important dates

Study start
2004
Study completion
2005
First posted
Aug 11, 2005
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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