Targeted Interventions for Weight-Concerned Smokers

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Naltrexone

Transdermal nicotine replacement

Behavioral counseling

About this trial

This is an interventional treatment trial for Nicotine Dependence focused on measuring Tobacco, Smoking, Weight, Weight perception, Naltrexone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Yale University School of Medicine Substance Abuse Treatment Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naltrexone, Transdermal Nicotine

Placebo Naltrexone, Transdermal Nicotine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight Gain at 26 Weeks.

Weight change from baseline measured at 26 weeks.

Point Prevalence Smoking Abstinence at 26 Weeks.

The number of people that were abstinent from cigarette smoking at 26 weeks.

Secondary Outcome Measures

Weight Gain at 6 Weeks.

Weight change from baseline measured at 6 weeks.

Point Prevalence Smoking Abstinence at 6 Weeks

The number of people that were abstinent from cigarette smoking at 6 weeks.

Cigarettes Smoked Per Day.

Average number of cigarettes smoked per day at 26 weeks.

Full Information

NCT ID

NCT00105482

First Posted

March 14, 2005

Last Updated

January 28, 2013

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00105482

Brief Title

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

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nicotine Dependence

Keywords

Tobacco, Smoking, Weight, Weight perception, Naltrexone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

172 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naltrexone, Transdermal Nicotine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Naltrexone, Transdermal Nicotine

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Intervention Description

Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks

Intervention Type

Drug

Intervention Name(s)

Transdermal nicotine replacement

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Behavioral counseling

Intervention Description

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.

Primary Outcome Measure Information:

Title

Weight Gain at 26 Weeks.

Description

Weight change from baseline measured at 26 weeks.

Time Frame

26 weeks

Title

Point Prevalence Smoking Abstinence at 26 Weeks.

Description

The number of people that were abstinent from cigarette smoking at 26 weeks.

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Weight Gain at 6 Weeks.

Description

Weight change from baseline measured at 6 weeks.

Time Frame

6 weeks

Title

Point Prevalence Smoking Abstinence at 6 Weeks

Description

The number of people that were abstinent from cigarette smoking at 6 weeks.

Time Frame

6 weeks

Title

Cigarettes Smoked Per Day.

Description

Average number of cigarettes smoked per day at 26 weeks.

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie O'Malley, PhD

Organizational Affiliation

Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine Substance Abuse Treatment Unit

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20542391

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.

Results Reference

result

Links:

URL

http://www.quitwithyale.org

Description

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.

Nicotine Dependence

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial