Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Benjamin A. Toll, Yale University Identifier:
First received: August 9, 2005
Last updated: January 2, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Nicotine Dependence
Drug: Naltrexone
Drug: Bupropion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Naltrexone & Bupropion to Stop Smoking With Less Weight Gain

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Smoking Cessation [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.

  • Point Prevalence Abstinence [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.

  • Weight Gain [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Weight gain for for the entire sample in pounds at 6 weeks.

Secondary Outcome Measures:
  • Weight Gain Abstinent Participants [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.

Enrollment: 40
Study Start Date: December 2004
Study Completion Date: December 2005
Arms Assigned Interventions
Active Comparator: Bupropion only
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
Drug: Bupropion
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.
Experimental: Naltrexone +Bupropion
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
Drug: Naltrexone
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.
Drug: Bupropion
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.

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00129246

United States, Connecticut
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Principal Investigator: Benjamin Toll, Ph.D. Yale University School of Medicine Department of Psychiatry
  More Information

Responsible Party: Benjamin A. Toll, Associate Professor, Yale University Identifier: NCT00129246     History of Changes
Other Study ID Numbers: NIAAAOMA15632-B, P50AA015632, NIH Grant 9 P50-AA15632
Study First Received: August 9, 2005
Results First Received: January 2, 2013
Last Updated: January 2, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Weight perception

Additional relevant MeSH terms:
Weight Gain
Body Weight
Body Weight Changes
Signs and Symptoms
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2014