Phase 2
Completed N=40
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Smoking · Nicotine Dependence
Source: ClinicalTrials.gov NCT00129246 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Smoking Cessation — 6; 6 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Cessation |
6; 6 | — |
| PRIMARY Point Prevalence Abstinence |
8; 8 | — |
| PRIMARY Weight Gain |
1.25; 0.28 | — |
| SECONDARY Weight Gain Abstinent Participants |
3.17; 1.67 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00129246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.