Targeted Interventions for Weight-Concerned Smokers

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Naltrexone; Nicotine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.