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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA015632 | U.S. NIH Grant/Contract | View source | |
| 9P50AA015632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone, Transdermal Nicotine | 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 |
|
| Placebo Naltrexone, Transdermal Nicotine | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain at 26 Weeks. | Weight change from baseline measured at 26 weeks. | 26 weeks |
| Point Prevalence Smoking Abstinence at 26 Weeks. | The number of people that were abstinent from cigarette smoking at 26 weeks. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain at 6 Weeks. | Weight change from baseline measured at 6 weeks. | 6 weeks |
| Point Prevalence Smoking Abstinence at 6 Weeks | The number of people that were abstinent from cigarette smoking at 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie O'Malley, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine Substance Abuse Treatment Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20542391 | Result | 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. |
| Label | URL |
|---|---|
| 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. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naltrexone | 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 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 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 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. |
| FG001 | Placebo | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Naltrexone | 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 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 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Gain at 26 Weeks. | Weight change from baseline measured at 26 weeks. | All patients who were randomized comprised the primary ITT population. | Posted | Mean | Standard Deviation | pounds | 26 weeks |
|
26 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naltrexone | 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 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 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 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment | Anxiety leading to hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Samples O'Malley PhD, Director, Division of Substance Abuse Research | Yale School of Medicine, Department of Psychiatry | (203) 974-7590 | stephanie.omalley@yale.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Transdermal nicotine replacement | Drug | 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 counseling | Behavioral | 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. |
|
| 6 weeks |
| Cigarettes Smoked Per Day. | Average number of cigarettes smoked per day at 26 weeks. | 26 weeks |
| Withdrawal by Subject |
|
| Lost Interest |
|
| Scheduling Conflict |
|
| Withdrawn by PI |
|
| BG001 | Placebo | 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 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | 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 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. |
|
|
| Primary | Point Prevalence Smoking Abstinence at 26 Weeks. | The number of people that were abstinent from cigarette smoking at 26 weeks. | All patients who were randomized comprised the primary ITT population. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Weight Gain at 6 Weeks. | Weight change from baseline measured at 6 weeks. | All patients who were randomized comprised the primary ITT population. | Posted | Mean | Standard Deviation | pounds | 6 weeks |
|
|
|
| Secondary | Point Prevalence Smoking Abstinence at 6 Weeks | The number of people that were abstinent from cigarette smoking at 6 weeks. | All patients who were randomized comprised the primary ITT population. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Cigarettes Smoked Per Day. | Average number of cigarettes smoked per day at 26 weeks. | Patients were analyzed per protocol. | Posted | Mean | Standard Deviation | number of cigarettes | 26 weeks |
|
|
|
| 2 |
| 87 |
| 51 |
| 87 |
| EG001 | Placebo | 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 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 | 85 | 51 | 85 |
|
| Abnormal EKG | Cardiac disorders | Systematic Assessment | Abnormal EKG leading to hospitalization. |
|
| Finger Laceration | General disorders | Systematic Assessment | Patient accidentally cut their finger with a saw, injury resulted in hospitalization. |
|
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Patient was diagnosed with Thyroid Cancer. |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Increased Bowel Freq | Gastrointestinal disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Change in Libido | General disorders | Systematic Assessment |
|
| Missed Period | Reproductive system and breast disorders | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Rapid Heartbeat | Cardiac disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sleepiness | General disorders | Systematic Assessment |
|
| Sweating | Endocrine disorders | Systematic Assessment |
|
| Vivid Dreams | Psychiatric disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |