Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Phase 1

Completed

Conditions: Smoking

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

Registration Number: NCT02927847

Lead Sponsor: Maggie M Sweitzer, PhD

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 35

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BA + VLNC	SPECTRUM Nicotine Research Cigarettes (.03 mg)	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.
BA + VLNC	Behavioral Activation	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.
VLNC Only	Nicotine Patch	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.
VLNC Only	SPECTRUM Nicotine Research Cigarettes (.03 mg)	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.
VLNC Only	Supportive Counseling	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.
BA + VLNC	Nicotine Patch	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.

Primary Outcome Measures

Name	Time	Method
Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward	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.
Number of Participants Who Relapsed or Are Presumed to Have Relapsed	weeks 6 to 13	Relapse is defined as return to 7 consecutive days of smoking.
Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward	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.