Status:
COMPLETED
Targeted Interventions for Weight-Concerned Smokers
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
This is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. Participants also receive tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00105482
Start Date
January 1 2005
End Date
October 1 2009
Last Update
March 5 2013
Active Locations (1)
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1
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511