Phase 2 Completed N=172 Randomized Triple-blind Treatment

Targeted Interventions for Weight-Concerned Smokers

Nicotine Dependence

Source: ClinicalTrials.gov NCT00105482 ↗

Enrolled (actual)

172

Serious AEs

2.3%

Results posted

Mar 2013

Primary outcomePrimary: Weight Gain at 26 Weeks. — 6.75; 9.71 pounds

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Gain at 26 Weeks.	6.75; 9.71	—
PRIMARY Point Prevalence Smoking Abstinence at 26 Weeks.	19; 23	—
SECONDARY Weight Gain at 6 Weeks.	2.53; 2.19	—
SECONDARY Point Prevalence Smoking Abstinence at 6 Weeks	33; 43	—
SECONDARY Cigarettes Smoked Per Day.	7.10; 7.85	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00105482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.