Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time.

NCT04130698 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: 1819-1483R15DA045917-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study has two phases. In Phase 1, the investigators will revise and pilot the distress tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20 GM103430, Spas, PI). Despite the 4-week post-intervention treatment outcomes demonstrating the DT protocol's association with smoking cessation and weight loss, several revisions to the DT protocol are important to improve the intervention. First, the investigators will include the overweight/obese smokers' group-level feedback that the investigators collected during the 7-week intervention and at the 4-week post-intervention individual interviews to tailor the DT protocol to meet the unique needs of smokers with excess weight. Subjects from the previous study revealed factors that led to current and/or previous successful smoking cessation and weight loss efforts, barriers to sustaining current and/or previous successful smoking cessation and weight loss efforts, and general feedback about DT intervention for both health risks. The investigators believe revising the DT protocol to include overweight/obese smokers' unique experience with the novel intervention and their acumen about these key factors will improve the intervention and its generalizability to smokers with excess weight. Additional revisions are described elsewhere. After the investigators pilot the revised DT protocol, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to ensure both protocols equate for intervention contact time. Although both protocols will have some similar content, to avoid any threats to internal validity, no DT-specific material will be included in the control. In Phase 2, the investigators will conduct a two-armed, preliminary randomized controlled trial (RCT) to compare the revised DT protocol's efficacy to the active health control protocol.

Conditions

Smoking Cessation; Weight Loss

Outcome Measures

Primary Outcomes (2)

• 7-day point-prevalence abstinence from smoking

  saliva cotinine assays

  6-month follow-up assessments from the end of intervention.

• 5% lower weight from baseline.

  weigh-ins

  6-month follow-up assessments from the end of intervention

Secondary Outcomes (1)

• Include latency to first smoking lapse and latency to smoking relapse

  6-month follow-up assessments from the end of intervention.

Study Arms (2)

Distress Tolerance

EXPERIMENTAL

Treatment rationale: RAs will explain that there are 3 (not 2 as in the control) key factors that maintain smoking behavior and excess weight: 1) learned habits, 2) the addictive properties of smoking and food, and 3) a way to manage distress. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address all 3 key factors. This condition includes both key factors in the control but introduces the third key factor distress tolerance (DT). Toward that end, modules will include: a values discussion; experiential avoidance; distress tolerance; and mindfulness-based ways to manage distress. Module 1: Orientation \& ACT; Module 2: Avoidance; Module 3: Cognitive Fusion vs. Defusion; Module 4: Self-As-Context; Module 5: Present-Moment-Awareness; and Module 6: Values and Committed Action.

Behavioral: Distress Tolerance; Drug: transdermal nicotine patch

Active Health Control

ACTIVE COMPARATOR

Treatment rationale: RAs will explain that there are 2 key factors that maintain smoking behavior and excess weight: 1) learned habits and 2) the addictive properties of smoking and food. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address both key factors. Toward that end, modules will include standard treatment on: the dangers of smoking, excess weight, unhealthy diets and sedentariness; the importance of healthy behaviors; and relaxation exercises to manage stress. These are all key aspects of standard treatment for smoking cessation and weight loss. Module 1: Orientation and Health; Module 2: Game Plan; Module 3: Stress and Coping Strategies; Module 4: Physical Activity; Module 5: Changes in Activities, Habits and Lifestyle; and Module 6: Long-Term Rewards.

Drug: transdermal nicotine patch; Behavioral: Active Health Control

Interventions

Distress Tolerance BEHAVIORAL

The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with distress tolerance intervention to quit smoking and lose weight.

Distress Tolerance

transdermal nicotine patch DRUG

Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week.

Also known as: the "patch"

Active Health Control; Distress Tolerance

Active Health Control BEHAVIORAL

The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with psychoeducation intervention to quit smoking and lose weight.

Also known as: Psychoeducation

Active Health Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• between 18-64 years old
• have been a regular smoker for at least three years
• meet DSM-IV criteria for nicotine dependence
• smoke on average 10 cigarettes per day
• are overweight or obese (25\<BMI\<40)
• report motivation to quit smoking and lose weight
• speak English.

You may not qualify if:

• engaged in a smoking cessation or weight loss intervention
• use medications known to affect smoking cessation or weight loss
• have a medical condition that is a contraindication for transdermal nicotine patch (TNP)
• regularly use other tobacco products
• endorse active suicidal or homicidal ideation
• self-report or meet diagnostic criteria for an alcohol or drug dependence
• self-report or meet diagnostic criteria for an eating or neurocognitive disorder

Sponsors & Collaborators

• Rhode Island College: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rhode Island College

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Weight Loss

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jayson J Spas, PhD, MS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 17, 2019
• Study Start: June 1, 2019
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)