Targeted Interventions for Weight-Concerned Smokers - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00105482

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 II

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Naltrexone Naltrexone hydrochloride Nicotine polacrilex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-Cessation Weight Gain

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Point prevalence smoking abstinence at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Weight gain at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other measures of smoking cessation success (e.g., continuous abstinence at 6 months) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Point prevalence smoking abstinence at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
alcohol consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
food preferences [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	172
Study Start Date:	January 2005
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator 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	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.

Arms

Assigned Interventions

1: Experimental

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.

2: Placebo Comparator

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

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

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Stephanie O'Malley, PhD

Yale School of Medicine

More Information

Additional Information:

This website describes the Transdisciplinary Tobacco Use Research Center at Yale University. Click here for more information about the study: Targeted Interventions for Weight-concerned Smokers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Yale University ( Stephanie O'Malley, Ph.D., Professor )
Study ID Numbers:	NIAAAOMA15632, 9 P50-AA15632
Study First Received:	March 14, 2005
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00105482 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Tobacco
Smoking
Weight
Weight perception
Naltrexone

Study placed in the following topic categories:

Nicotine polacrilex
Neurotransmitter Agents
Nicotinic Agonists
Tobacco Use Disorder
Narcotic Antagonists
Disorders of Environmental Origin
Narcotics
Cholinergic Agents

Weight Gain
Body Weight
Smoking
Mental Disorders
Nicotine
Naltrexone
Substance-Related Disorders
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Nicotinic Agonists
Tobacco Use Disorder
Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Cholinergic Agents
Pharmacologic Actions

Autonomic Agents
Mental Disorders
Nicotine
Sensory System Agents
Therapeutic Uses
Naltrexone
Ganglionic Stimulants
Substance-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009