Effect of Tetrahydrocannabinol (THC) on Sleep in Humans

IRB00018052

The investigators will test the effects of 10-60mg dronabinol (oral THC) on sleep in non-frequent and frequent cannabis users.

2018-09-01

2021-09-19

2025-04-01

Active (not recruiting)

Early phase I

18

Inclusion Criteria: * Frequent Cannabis Use (\>3x/week for the prior 3 months) or * No Cannabis Use (Less than 10x ever) Exclusion Criteria: * Sleep Apnea * Pregnancy * Diabetes * Cardiovascular disease * Chronic Pain * History of seizures * Severe Hepatic impairment * Conditions associated with clinically relevant cognitive impairment * Symptoms of acute or active illness (e.g., fever and leukocytosis) * Evidence of psychopathology on the Beck Depression Index II (BDI-II or in a structured clinical interview with a physician * History of severe psychiatric illnesses (including such as alcoholism, drug dependency including a cannabis use disorder score ≥12 on the Cannabis Use Disorders Identification Test (CUDIT) (28) or \>1 withdrawal symptom on the Marijuana Withdrawal Checklist (MWC (29)) , major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder.) * History of having been treated with antidepressants, neuroleptic medications, or tranquilizers. * Volunteers must be drug-free (including caffeine, nicotine, alcohol and herbal medications) for the duration of the screening and study period (with the exception of THC), with no dependence on drugs (e.g. cocaine, opioids, amphetamine, methamphetamine, PCP, benzodiazepines, barbiturates, methadone, MDMA); or alcohol dependency. * Current Nicotine use ( or history of more than 5 'pack years' of smoking) * Current use of prescription or over the counter medications * History of shift work in the last 6 months * Travel across \>2 time zones during the month prior to the study * Habitual bedtime after 1am or waketime before 5am

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are initially categorized as non-frequent or frequent cannabis users based on their cannabis use behavior and then receive the same treatment of 10-60mg dronabinol upon participation in the study.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2024-04-15