Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Maggie M Sweitzer, PhD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Smoking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02927847

Pro00076408

K23DA039294 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

BA + VLNC

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral Activation

Drug: Nicotine Patch

Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg)

VLNC Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supportive Counseling

Drug: Nicotine Patch

Drug: SPECTRUM Nicotine Research Cigarettes (.03 mg)