Phase 2
Completed N=35
Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation
Source: ClinicalTrials.gov NCT02927847 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward — -0.085; -0.067 fMRI BOLD signal — p=0.891
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in BOLD (Blood-oxygen-level-dependent) Response to Monetary Reward |
-0.085; -0.067 | 0.891 |
| PRIMARY Change in BOLD (Blood-oxygen-level-dependent) Response to Smoking Reward |
0.011; -0.036 | 0.571 |
| PRIMARY Number of Participants Who Relapsed or Are Presumed to Have Relapsed |
9; 9 | 0.739 |
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
Data sourced from ClinicalTrials.gov (NCT02927847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.