Clinical trial NCT02927847: Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation
Official title: Targeting Reward Dysfunction as a Mechanism to Improve Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-10-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward
timeFrame: baseline, week 5
measure: Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward
timeFrame: baseline, week 5
measure: Number of Participants Who Relapsed or Are Presumed to Have Relapsed
timeFrame: weeks 6 to 13
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Maggie M Sweitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: