Phase 2
Completed N=67
Translational Neuropsychopharmacology Research of Nicotine Addiction
Nicotine Dependence, Cigarettes
Source: ClinicalTrials.gov NCT02723162 ↗
Enrolled (actual)
67
Serious AEs
3.0%
Results posted
Aug 2022
Primary outcomePrimary: Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response — -0.09; 1.07; 0.08; 1.19 Percentage change
Summary
This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC) on neural circuitry function and treating nicotine addiction. Healthy adult nicotine dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO. Following 1 week of medication, participants will be contingently reinforced for 3 days of smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI) techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task. Participants will be followed over the next 3 weeks of treatment and clinical variables will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Blood Oxygen Level Dependent (BOLD) Signal Response |
-0.09; 1.07; 0.08; 1.19; 0.11; 0.91 | — |
| PRIMARY rZ Change Score in Resting State Functional Connectivity From Baseline |
.297; .060; .181; .191 | — |
| SECONDARY Number of Cigarettes Smoked Per Day |
5.3; 4.0; 5.3; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 - 55
- Right Handed
- English fluency
- 20/20 vision with corrective lenses.
- Smoke ≥ 10 cigarettes/day for a minimum of two years and have an expired carbon monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation).
- Interest in quitting smoking or contemplating a quit attempt in the next 6 months
- If female, agreement to use birth control
Exclusion Criteria
- Past head injury or primary neurological disorder associated with MRI abnormalities, including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating diseases
- Any physical or intellectual disability affecting completion of assessments
- Any contraindication to MRI
- Positive urine drug screen for illicit substances (such as marijuana or cocaine).
- Current or past psychosis
- Electroconvulsive therapy in last 6 months
- Use of antidepressant medications or other psychotropic medications in the last month.
- Positive urine pregnancy test or current breast feeding status
Data sourced from ClinicalTrials.gov (NCT02723162). 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.