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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DA064898-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this research study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery. The intervention will be compared to a standard of care control group.
Smoking prevalence among pre-bariatric surgery patients is estimated to be as high as 40%. In addition to quitting smoking, patients are expected to lose weight before surgery, which is challenging as smoking cessation is associated with weight gain. This study aims to evaluate a multiple health behavior change intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion) for weight loss and smoking cessation for adults seeking bariatric surgery. This pilot randomized control trial will evaluate feasibility and acceptability of the intervention and compare the intervention to a standard of care control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MHBC Intervention Group | Experimental | Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion). |
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| Control Group | No Intervention | Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone hydrochloride | Drug | Participants will be given 50mg/day of Naltrexone for 4 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Study enrollment to assess Feasibility | Number of participants enrolled out of participants screened. | 16 weeks |
| Mean number treatment sessions attended to assess Feasibility | Mean number of treatment sessions attended. | 16 weeks |
| Retention to assess Feasibility | Retention will be measured as the percent of participants that attend the post treatment assessment. | 16 weeks |
| Treatment credibility to assess Acceptability | Treatment credibility will be assessed via self-report monthly. Acceptability measured as the percent of participants that agree the intervention is acceptable (0-100%, with higher scores being indicative of higher treatment credibility). | Week 4, Week 8, Week 12, Week 16 |
| Treatment satisfaction to assess Acceptability | Treatment satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is satisfactory (0-100%, with higher scores being indicative of higher treatment satisfaction). | Week 16 |
| Percent weight change | Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up. | Baseline, Week 16, 6-month follow-up |
| Smoking cessation, as measured by exhaled carbon monoxide |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence | The Fagerstrom Test for Nicotine Dependence is a self-report measure that classifies level of nicotine dependence. Participants respond to a series of questions assessing time of first cigarette after waking, difficulty refraining from smoking in places where smoking is prohibited, and frequency of smoking. Total score range 0-10 with higher scores indication more nicotine dependence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlin E Smith, PhD | Contact | 203-785-7210 | smithcai@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Caitlin E Smith, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32524412 | Background | Chow A, Neville A, Kolozsvari N. Smoking in bariatric surgery: a systematic review. Surg Endosc. 2021 Jun;35(6):3047-3066. doi: 10.1007/s00464-020-07669-3. Epub 2020 Jun 10. |
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Participants will be randomly assigned to the active intervention group or the standard of care control group.
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| Bupropion Hydrochloride Extended-release | Drug | Participants will be given 300mg/day of Bupropion for 4 months. Bupropion will be taken twice daily (150mg in the morning, followed by 150mg in the late afternoon/early evening). |
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| Cognitive-Behavioral Therapy | Behavioral | Participants will receive cognitive-behavioral therapy for weight loss and smoking cessation. Participants will meet with their assigned study clinician weekly for 60 minutes for 4 months. |
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Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
| Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up |
| Smoking cessation, as measured by timeline followback interview | Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews. | Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up |
| Baseline, Week 16, 6-month follow-up |
| Depressive symptomatology, as measured by the Patient Health Questionnaire-9 | The Patient Health Questionnaire-9 is a brief, psychometrically sound, and widely used self-report measure of depression in diverse medical settings. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. | Baseline, Week 16, 6-month follow-up |
| Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ) | GPAQ is a validated self-report assessment of physical activity and sedentary behavior. GPAQ does not have a single fixed total score range but a score is calculated in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week. | Baseline, Week 16, 6-month follow-up |
| Number of participants with Bariatric surgery completion | Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review. | 6-month follow-up |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | 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 |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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