Intoxication Alcohol Clinical Trial
— fNIRSOfficial title:
Using Imaging to Assess Effects of THC on Brain Activity
Verified date | July 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 316 |
Est. completion date | January 21, 2021 |
Est. primary completion date | January 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria General 1. Men and women aged 18-55 years, inclusive; (for Phase 2B: men and women aged 21-55 years, inclusive) 2. Competent and willing to provide written informed consent; 3. Able to communicate in English language. 4. Regular, at least monthly, marijuana use, confirmed by positive urine screen for THC Additional Inclusion Criteria For Phase 2B: 5. Past consumption of at least two alcoholic beverages in one occasion. 6. Past co-consumption of alcohol and THC at least once in lifetime with no serious adverse effects. 7. Weigh more than 100 lbs. Exclusion Criteria: General (Phase 2A, 2B 3) 1. Any unstable, serious medical illness, or cardiovascular disease or events. 2. New or unstable psychiatric symptoms, schizophrenia, or bipolar I disorder, 3. Diabetes, cirrhosis, renal failure, Hepatitis C, HIV, 4. History of syncope without an identified situational stressor, migraines >1x/month, head injury with prolonged unconsciousness (> 24 hours); 5. Allergy to sesame oil (contained in Marinol pills) or Marinol capsules 6. Daily use of benzodiazepines or barbiturates, antihistamines, atropine, scopolamine, or other strong anticholinergic agents; 7. Current pregnancy or lactation, or trying to become pregnant (confirmed by urine pregnancy test) 8. In the opinion of the investigator, not able to safely participate in this study. Additional Exclusion Criteria For Phase 2B: 9. Currently seeking treatment, in treatment, or in recovery from an alcohol use disorder. |
Country | Name | City | State |
---|---|---|---|
United States | Center for Addiction Medicine, Massachusetts General Hospital, Dept. of Psychiatry | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans During Resting State. | Subjects completed resting-state fNIRS scans before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture concentration of oxygenated hemoglobin to assess prefrontal brain activity.
Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). |
The first resting-state scan session was run before dosing (t ˜ -45min). Drug was administered (t = 0min). The second resting-state scan session was run at the time of expected peak high (t ˜ 90min). Each scan session was six minutes in duration. | |
Primary | Change in Concentration of Oxygenated Hemoglobin Between Pre-drug and Post-drug Scans of Patients Completing the N-back Task. | Subjects completed the N-back task before and after receiving a combination of active dronabinol or placebo dronabinol and active ethanol or placebo ethanol. During the task, the fNIRS device was used to capture change in concentration of oxygenated hemoglobin to assess prefrontal brain activity.
Outcomes reflect average change from baseline in HbO concentration over pre-dose scan and average change from baseline in HbO concentration over post-dose scan (expected peak intoxication). |
The first Nback scan session was run before dosing (t ˜ -35min). Drug was administered (t = 0min). The second Nback scan session was run at the time of expected peak pharmacokinetic effect (t ˜ 100min). Each scan session was six minutes in duration. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03608787 -
Stop-Service to Obviously-Impaired Patrons
|
N/A | |
Recruiting |
NCT04474444 -
Ambulance Calls for Substance Use and Alcohol in a Pandemic (ASAP)
|
||
Completed |
NCT04878653 -
Alcohol-Containing Products' Effect on Breathalyzer Results in Healthy Adults Without Acute Intoxication
|