Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Smoking Clinical Trial

Official title:

Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927847
• Other study ID #: Pro00076408
• Secondary ID: K23DA039294
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2017
• Est. completion date: May 27, 2022

Study information

• Verified date: June 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Smokers who are interested in quitting will be randomly assigned to one of two treatment conditions. In the BA +VLNC condition (n = 16) smokers will switch to smoking very low nicotine cigarettes (VLNCs) while wearing a 21 mg/d nicotine patch for 5 weeks prior to their quit date. They will also participate in weekly behavioral activation (BA) treatment sessions. Smokers in the VLNC Only group (n = 19) will undergo the same pharmacological pretreatment but will undergo standard counseling and health education instead of BA. Following the quit date, both groups will receive standard nicotine replacement therapy. At baseline and pre-quit, BOLD response to smoking and non-smoking rewards will be measured using fMRI after 24 hr abstinence. Latency to relapse will serve as a continuous clinical outcome measure. Participants will also receive follow-up phone calls at 6 months and 12 months post-quit to assess smoking status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 27, 2022
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Nicotine Patch
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).
• SPECTRUM Nicotine Research Cigarettes (.03 mg)
For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.

Behavioral:
• Behavioral Activation
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.
• Supportive Counseling
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Maggie M Sweitzer, PhD	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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