Targeted Interventions for Weight-Concerned Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00105482
First received: March 14, 2005
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Drug: Naltrexone
Drug: Transdermal nicotine replacement
Behavioral: Behavioral counseling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-cessation Weight Gain

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Weight Gain at 26 Weeks. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Weight change from baseline measured at 26 weeks.

  • Point Prevalence Smoking Abstinence at 26 Weeks. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    The number of people that were abstinent from cigarette smoking at 26 weeks.


Secondary Outcome Measures:
  • Weight Gain at 6 Weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Weight change from baseline measured at 6 weeks.

  • Point Prevalence Smoking Abstinence at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The number of people that were abstinent from cigarette smoking at 6 weeks.

  • Cigarettes Smoked Per Day. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Average number of cigarettes smoked per day at 26 weeks.


Enrollment: 172
Study Start Date: January 2005
Study Completion Date: October 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone, Transdermal Nicotine
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
Drug: Naltrexone
Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Drug: Transdermal nicotine replacement
Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Behavioral: Behavioral counseling
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.
Placebo Comparator: Placebo Naltrexone, Transdermal Nicotine
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
Drug: Transdermal nicotine replacement
Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Behavioral: Behavioral counseling
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105482

Locations
United States, Connecticut
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Stephanie O'Malley, PhD Yale School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00105482     History of Changes
Other Study ID Numbers: NIAAAOMA15632, P50AA015632, 9 P50-AA15632
Study First Received: March 14, 2005
Results First Received: January 28, 2013
Last Updated: January 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Tobacco
Smoking
Weight
Weight perception
Naltrexone

Additional relevant MeSH terms:
Naltrexone
Nicotine
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014