N/A
N=184
Brain Nicotine Receptor Density in Veteran Smokers
Positron Emission Tomography
Bottom Line
View on ClinicalTrials.gov: NCT01721473 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: PET Scan, Rating Scales — 7.1; 8.6; 7.9; 8.0 Vt/fp or mL/cm3
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- positron emission tomography scan (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PET Scan, Rating Scales |
7.1; 8.6; 7.9; 8.0; 11.9; 10.8 | — |
Summary
Cigarette smoking is more prevalent among Veterans (27%) than the general U.S. population (21%). Smoking is common among people who use marijuana or caffeine heavily, and the use of menthol cigarettes is becoming increasingly common, affecting approximately 9% of the Veteran population. Recent research by the group and others indicates that heavy marijuana or caffeine use, or the use of predominantly menthol cigarettes, can alter brain nicotinic acetylcholine receptor (nAChR) densities. For the proposed study, brain imaging with PET scanning will be used to determine nicotine receptor densities in Veteran cigarette smokers with and without heavy marijuana or caffeine use, and in menthol and non-menthol Veteran smokers. Results of the proposed research may have implications for improving treatments for Veterans who smoke cigarettes and who have specific drug use co-morbidities or who use menthol cigarettes.
Eligibility Criteria
Inclusion Criteria
- Must be a Veteran cigarette smoker, living within commuting distance of the VA San Diego Healthcare System
- Healthy adult Veterans (18 to 65 years old) who are tobacco dependent cigarette smokers (10 to 40 cigarettes per day) meeting criteria for Nicotine Dependence as defined by DSM-IV criteria109 and who want to quit smoking.
- Heavy marijuana or caffeine use (defined as using the equivalent of > 2 marijuana cigarettes per week or the use of at least 3 coffee cup equivalents per day) for at least the past 6 months or no heavy drug/alcohol use.
- Ability to read, write, and give voluntary informed consent.
- An exhaled CO > 8 ppm during the study screening visit to verify smoking status.
Exclusion Criteria
- Any Axis I diagnosis (including mood, anxiety, and psychotic disorders) other than Nicotine, Marijuana, or Caffeine Dependence within the past 1 year.
- A current diagnosis (within the past month) of other substance abuse/dependence diagnoses (such as cocaine, amphetamine, or opiates). (Length of abstinence will be verified through participant interview and a chart review at the initial study visit, which typically includes information about substance abuse treatment history and objective verification with breathalyzer and/or urine toxicology screens). Occasional drug/alcohol use not meeting criteria for abuse/dependence will not be exclusionary.
- Any current medication or any history of a medical condition that might affect the central nervous system at the time of scanning (e.g., current treatment with a psychotropic medication, or history of severe head trauma with loss of consciousness, epilepsy, or other neurological diseases).
- The combination of both heavy marijuana and caffeine use.
- Unstable cardiovascular disease, severe liver disease, or renal insufficiency, which might make tolerating study procedures difficult. Routine history and physical examination will be performed at the initial screening visit to insure that participants meet study criteria (Section D4).
- Pregnancy (urine pregnancy tests will be obtained on all women of childbearing potential) due to the theoretical risk of radiation exposure to the fetus.
Data sourced from ClinicalTrials.gov (NCT01721473). 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.