N/A
N=190
Using Imaging to Assess Effects of THC on Brain Activity
Intoxication Alcohol · Intoxication THC · Intoxication Combined Alcohol THC
Bottom Line
View on ClinicalTrials.gov: NCT03655717 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. — 0.00000000042; -0.00000000126; -0.00000000271; -0.00000000114 Δ mol/L — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dronabinol (Drug); Ethanol (Drug); Placebo dronabinol (Drug); Placebo ethanol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. |
0.00000000042; -0.00000000126; -0.00000000271; -0.00000000114; -0.00000000151; -0.00000000219 | 0.94 |
Summary
This study will assess effects of tetrahydrocannabinol (THC) and THC + alcohol in marijuana users on prefrontal brain activity, using functional near-infrared spectroscopy (fNIRS) during resting state and during memory task performance. Participants will complete fNIRS testing 120 minutes following THC or identical placebo (Phase 2A), or THC/ethanol, THC/placebo ethanol, placebo THC/ethanol, and placebo THC/placebo ethanol (Phase 2B), and oxygenated hemoglobin (HbO) concentration will be measured.
Eligibility Criteria
Inclusion Criteria General
- Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive)
- Competent and willing to provide written informed consent;
- Able to communicate in English language.
- Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC
Additional Inclusion Criteria For Phase 2B:
- Past consumption of at least two alcoholic beverages in one occasion.
- Past co-consumption of alcohol and THC at least once in lifetime with no serious adverse effects.
- Weigh more than 100 lbs.
Exclusion Criteria
General (Phase 2A, 2B 3)
- Any unstable, serious medical illness, or cardiovascular disease or events.
- New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder,
- Diabetes, cirrhosis, renal failure, Hepatitis C, HIV,
- History of syncope without an identified situational stressor, migraines >1x/month, head injury with prolonged unconsciousness (> 24 hours);
- Allergy to sesame oil (contained in Marinol pills) or Marinol capsules
- Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents;
- Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test)
- In the opinion of the investigator, not able to safely participate in this study.
Additional Exclusion Criteria For Phase 2B:
- Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder.
Data sourced from ClinicalTrials.gov (NCT03655717). 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.