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

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

Interventions

BEHAVIORAL

Distress Tolerance

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.

DRUG

transdermal nicotine patch

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.

BEHAVIORAL

Active Health Control

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Rhode Island College

  lead OTHER

Principal Investigators

• Jayson J Spas, PhD, MS · Associate Professor

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2022-07-31

Completion

2022-07-31

FDA Drug

Yes

Countries

• United States

Study Locations