Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

NCT02927847 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: Pro00076408K23DA039294
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effects of a smoking cessation intervention combining behavioral treatment with low nicotine cigarettes on neuroimaging measures of reward function and smoking cessation outcomes. The results of this study will provide information about mechanisms contributing to smoking and smoking cessation and will help to guide future treatment studies.

Conditions

Smoking

Outcome Measures

Primary Outcomes (3)

• Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward

  Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to monetary reward anticipation. BOLD signal change is estimated from the contrast of monetary reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.

  baseline, week 5

• Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward

  Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking reward anticipation. BOLD signal change is estimated from the contrast of smoking reward anticipation vs neutral anticipation, and extracted from voxels within the ventral striatum at each time point.

  baseline, week 5

• Number of Participants Who Relapsed or Are Presumed to Have Relapsed

  Relapse is defined as return to 7 consecutive days of smoking.

  weeks 6 to 13

Study Arms (2)

BA + VLNC

EXPERIMENTAL

Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during the quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus behavioral activation therapy aimed at increasing reinforcement from non-drug rewards.

Drug: Nicotine Patch; Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg); Behavioral: Behavioral Activation

VLNC Only

ACTIVE COMPARATOR

Participants will receive Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (.03), and behavioral treatment prior to quit attempt, followed by standard nicotine replacement therapy with Nicotine Patch during quit attempt. Behavioral treatments in this condition will include standard smoking cessation counseling plus supportive counseling and health education.

Drug: Nicotine Patch; Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg); Behavioral: Supportive Counseling

Interventions

Nicotine Patch DRUG

Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).

Also known as: Nicoderm CQ

BA + VLNC; VLNC Only

SPECTRUM Nicotine Research Cigarettes (.03 mg) DRUG

For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.

Also known as: Very Low Nicotine Content Cigarettes

BA + VLNC; VLNC Only

Behavioral Activation BEHAVIORAL

Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.

Also known as: BA

BA + VLNC

Supportive Counseling BEHAVIORAL

Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.

VLNC Only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• generally healthy
• intact intellectual functioning (K-BIT2 \>79)
• smoking at least 5 cigarettes per day
• expired CO concentration of at least 8 ppm or urinary cotinine \> 100 ng/mL
• interested in quitting smoking

You may not qualify if:

• inability to attend all experimental sessions
• report of significant health problems
• use of psychoactive medications or current participation in psychotherapy
• current unstable psychiatric illness as assessed by clinical diagnostic interview
• suicidal ideation with plan or intent
• regular use of smokeless tobacco
• current alcohol or drug abuse
• use of illegal drugs (excluding marijuana) as measured by urine drug screen
• current use of nicotine replacement therapy or other smoking cessation treatment
• presence of contraindications for nicotine replacement therapy
• left-handed
• presence of conditions that would make MRI unsafe
• claustrophobia
• history of fainting
• pregnant, trying to become pregnant, or breastfeeding

Sponsors & Collaborators

• Maggie M Sweitzer, PhD: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Maggie M Sweitzer, PhD
• Organization: Duke University

maggie.sweitzer@duke.edu

919-668-0094

Study Officials

• Maggie M Sweitzer, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 7, 2016
• Study Start: February 1, 2017
• Primary Completion: May 28, 2021
• Study Completion: May 27, 2022
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)