Clinical trial NCT00105482: Targeted Interventions for Weight-Concerned Smokers
Official title: Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: Tobacco
Smoking
Weight
Weight perception
Naltrexone
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-03-15
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 drug both improves smoking cessation quit rates and minimizes post quit weight gain.

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 transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. Naltrexone study medication will be started a week before their quit date and continued through the six-month period. Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. A follow-up appointment is completed at 12 months after participants' quit date.

The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent (not even a puff).

Secondary outcomes include an examination of alcohol consumption, evaluation of urges, other measures of smoking cessation success, point prevalence abstinence at 12 months, and food preferences. A number of tertiary measures will be obtained for examining predictors of smoking cessation, weight gain, and naltrexone response.

Eligibility 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.

Primary outcomes:
measure: Weight Gain at 26 Weeks.
timeFrame: 26 weeks
measure: Point Prevalence Smoking Abstinence at 26 Weeks.
timeFrame: 26 weeks
Secondary outcomes:
measure: Weight Gain at 6 Weeks.
timeFrame: 6 weeks
measure: Point Prevalence Smoking Abstinence at 6 Weeks
timeFrame: 6 weeks
measure: Cigarettes Smoked Per Day.
timeFrame: 26 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine Substance Abuse Treatment Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Stephanie O'Malley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O'Malley SS. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. doi: 10.1016/j.drugalcdep.2010.04.015. Epub 2010 Jun 12.