We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

This study is currently recruiting participants.
Verified May 2017 by Maggie M Sweitzer, PhD, Duke University Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02927847
First Posted: October 7, 2016
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Maggie M Sweitzer, PhD, Duke University Medical Center
  Purpose
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.

Condition Intervention Phase
Smoking Depressive Symptoms Drug: Nicotine Patch Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg) Behavioral: Behavioral Activation Behavioral: Supportive Counseling Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Maggie M Sweitzer, PhD, Duke University Medical Center:

Primary Outcome Measures:
  • Change in BOLD response to smoking and monetary reward [ Time Frame: baseline, week 5 ]
    Effects of BA+VLNC (vs. VLNC Only) on pre-quit changes in fMRI BOLD response to smoking and monetary reward anticipation

  • Days to Relapse [ Time Frame: weeks 6 to 13 ]
    Effects of BA+VLNC (vs. VLNC Only) on smoking cessation outcomes. Relapse is defined as return to 7 consecutive days of smoking


Estimated Enrollment: 100
Actual Study Start Date: February 1, 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BA + VLNC
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
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 Name: Nicoderm CQ
Drug: 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.
Other Name: Very Low Nicotine Content Cigarettes
Behavioral: Behavioral Activation
Participants in the BA+VLNC group will undergo 7 60-minute behavioral sessions (5 pre-quit and 2 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 Name: BA
Active Comparator: VLNC Only
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 brief relaxation training.
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).
Other Name: Nicoderm CQ
Drug: 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.
Other Name: Very Low Nicotine Content Cigarettes
Behavioral: Supportive Counseling
Participants in the VLNC Only group will undergo 7 60-minute behavioral sessions (5 pre-quit and 2 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling. Supportive counseling will include empathic listening and brief relaxation exercises.

Detailed Description:
Smokers with mild depressive symptoms who are interested in quitting will be randomly assigned to one of two treatment conditions. In the BA +VLNC condition (n = 24) 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 = 24) will undergo the same pharmacological pretreatment but will undergo standard counseling 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally healthy
  • intact intellectual functioning (K-BIT2 >79)
  • mild depressive symptoms (BDI >9)
  • 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 psychiatric illness as assessed by clinical diagnostic interview
  • suicidal ideation with plan or intent
  • 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
  • history of migraine headaches in the past 5 years
  • claustrophobia
  • history of fainting
  • pregnant, trying to become pregnant, or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02927847


Contacts
Contact: Maggie Sweitzer, PhD 919-668-0094 maggie.sweitzer@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Maggie Sweitzer, PhD    919-668-0094      
Sponsors and Collaborators
Maggie M Sweitzer, PhD
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Maggie M Sweitzer, PhD Duke University
  More Information

Responsible Party: Maggie M Sweitzer, PhD, Assistant Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT02927847     History of Changes
Other Study ID Numbers: Pro00076408
K23DA039294 ( U.S. NIH Grant/Contract )
First Submitted: October 6, 2016
First Posted: October 7, 2016
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action