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

• Status: Suspended
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhode Island College
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• 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- report motivation to quit smoking and lose weight

• speak English.

Exclusion Criteria:

• 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