N/A
Completed N=80
Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors
Source: ClinicalTrials.gov NCT02008292 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Change in Acetylcholine (ACh) Levels After Physostigmine Administration as Confirmed by PET Images. — 5.9; 4.3 percentage of change
Summary
The purpose of the study is to measure the sensitivity of NCFHEB binding to changes in endogenous acetylcholine levels in healthy smoking and nonsmoking subjects, and in schizophrenic smoking and nonsmoking subjects. We hypothesize that physostigmine-induced elevated ACh levels will lead to a reduction in the availability of nicotinic receptors for the binding of the radioligand. We hypothesize there will be greater increase in ACh level (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects. We hypothesize there will be greater increase in ACh level (or greater reduction in radio tracer binding) in smoking as compared to nonsmoking subjects with schizophrenia, but the extent of this change will be different than in controls.
We are also measuring the sensitivity of PHNO binding to changes in dopamine levels in healthy smoking and nonsmoking subjects before and after amphetamine challenge.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Acetylcholine (ACh) Levels After Physostigmine Administration as Confirmed by PET Images. |
5.9; 4.3 | — |
| PRIMARY Change in Dopamine (DA) Levels After Amphetamine Administration as Confirmed by PET Images. |
26.5; 19.6 | — |
Eligibility Criteria
Inclusion Criteria
- who are able to read and write
- who are able to give voluntary written informed consent
- have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
- have no history of a neurological or psychiatric disorder (DSMIV Axis 1 and 2) other than schizophrenia in schizophrenia subgroup
- have not regularly used any prescription, herbal or illegal psychotropic medications (e.g. antidepressants, antipsychotics, anxiolytics, ecstasy) in the past 6 months (controls).
- Subjects with schizophrenia have not used any herbal or illegal substances in the past 6 months (medication inclusion listed below in Aim 5)
- drink less than 100 bpm will be excluded
- Subjects with hypertension defined as sitting systolic blood pressure of >160 mmHg and/or sitting diastolic blood pressure of >100 mmHg will be excluded. Those individuals with hypertension that is well controlled by medication (e.g., within the above mentioned range) are not excluded
- Specifically, we will exclude subjects who have any active clinically significant deviation from the normal range in their electrocardiogram (EKG). However, subjects who have abnormalities in their EKG but the condition has been present for a while and the study cardiologist has evaluated and feels comfortable with the condition, would not be excluded on the basis of their cardiac condition. Examples of conditions that may meet these criteria (e.g., condition has been present for a while) include but are not limited to T-wave abnormalities, atrial fibrillation, prolonged PR interval, and right bundle branch block.
- Subjects with an allergy to salicylates
- Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
- Subjects with current, past or anticipated exposure to radiation in the work place
- Blood donation within eight weeks of the start of the study.
Data sourced from ClinicalTrials.gov (NCT02008292). 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.