Targeted Interventions for Weight-Concerned Smokers
Completed · Phase 2 · Has a placebo group
Conditions studied: Nicotine Dependence
In brief
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.
Key facts
- Study ID
- NCT00105482
- Run by
- Yale University
- People needed
- 172
- Starts
- 2005-01-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2013-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 1. Concern about gaining weight after quitting. This will be assessed using questionnaires that will provide a rating system to determine qualified participants.
- 2. Age 18 and older.
- 3. Willingness and ability to give written consent.
- 4. Smoking greater than 10 cigarettes per day for at least 1 year.
- 5. At least one prior attempt to stop smoking.
- 6. Baseline expired carbon-monoxide level of at least 10 ppm.
- 7. Weigh at least 100 lbs.
- 8. English speaking.
- 9. One person per household.
You may not qualify if…
- 1. Pregnant or nursing women or women attempting to conceive.
- 2. Unstable cardiac disease.
- 3. History of dermatoses.
- 4. Current alcohol or drug dependence other than nicotine dependence.
- 5. Serious current neurologic, psychiatric or medical illness, including those with a significant risk of committing suicide based on history or investigator's judgment.
- 6. Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist, will make these medications ineffective).
- 7. History of cirrhosis or significant hepatocellular injury as evidenced by SGOT or SGPT >3 x normal or elevated bilirubin.
- 8. Current use of smokeless tobacco, pipes, cigars, nicotine gum, patch, nasal spray, inhaler, or lozenges.
- 9. Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component except those who are on a stable dose of an Selective Serotonin Reuptake Inhibitor for at least two months for the indications of Major Depressive Disorder, Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD).
- 10. Subjects with a positive opiate urine drug screen will be excluded to avoid precipitating opiate withdrawal.
- 11. Current use of opiates.
- 12. Currently on a medically prescribed diet.
Where it is running
- Yale University School of Medicine Substance Abuse Treatment Unit — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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