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OpenTrials
Completed

NCT Number: NCT02927847

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Nicoderm CQ

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.

Other names: Very Low Nicotine Content Cigarettes

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.

Other names: BA

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.

Primary outcomes

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

    Time frame: baseline, week 5

    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.

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

    Time frame: baseline, week 5

    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.

  3. Number of Participants Who Relapsed or Are Presumed to Have Relapsed

    Time frame: weeks 6 to 13

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

Sponsors and collaborators

Lead sponsor

Maggie M Sweitzer, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Oct 7, 2016
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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