Cannabis Effects on Sleep, Circadian Rhythms, and Light Sensitivity in Young Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of Pittsburgh

About this trial

The goal of this study is to learn how cannabis use and discontinuation affect sleep, circadian rhythms, and sensitivity to light. The main questions it aims to answer are:

1. Does cannabis use and discontinuation impact sleep drive? 2. Does cannabis use and discontinuation impact light sensitivity and circadian phase?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-25 years

Physically and psychiatrically healthy, as determined by instruments described below

Cannabis-Using group only: Regular cannabis use, defined as "frequent" (6-29 days/month) or "daily" (daily) use over the past 3 months

Cannabis-Using group only: Willingness to discontinue cannabis for 4 weeks.

Disqualifiers

Significant or unstable acute or chronic medical conditions. Examples of such conditions include, but are not limited to, central nervous system disorders (e.g., head injury, seizure disorder, multiple sclerosis, tumor), cardiovascular or hemodynamically significant cardiac disease, liver disease (e.g., acute or chronic hepatitis, hepatic insufficiency), migraine or chronic headaches, active peptic ulcer disease, inflammatory bowel disease, renal failure, arthritis, and diabetes and other endocrine disorders. Seizure disorder in particular will be exclusionary due to the increased risk it confers for cannabis withdrawal symptoms. Eye/retinal conditions such as diabetic retinopathy or glaucoma will be exclusionary, although should be very rare in this population. Individuals with well-controlled health conditions that do not affect sleep, retinal function, and/or well-being (e.g., well-controlled thyroid disorders, asthma, or ulcer) will not be excluded. To evaluate these criteria, potential participants will complete a locally-developed Medical History Questionnaire.

Past or current DSM-5 bipolar disorder or psychotic disorders. Psychiatric disorders will be evaluated using the Mini International Neuropsychiatric Interview (MINI) and the WHO-DAS 2.0, supplemented by clinical interview. We will not exclude participants for subsyndromal symptoms or disorders in these domains. We will not exclude participants for other psychiatric disorders, particularly given the high comorbidity between cannabis use disorder and major depression and anxiety disorder, as long as severity is in the moderate range or lower based on the WHO-DAS 2.0 (average score <4).

Daily use of alcohol; regular use of illicit substances. Regular use (as defined above) of illicit substances other than cannabis over the past 3 months will be exclusionary. Substance use will be assessed using the Timeline Follow Back method, as well as a urine drug screen.

Past or current substance use disorders other than cannabis use disorder, nicotine use disorder, and mild alcohol use disorder (moderate and severe alcohol use disorder are exclusionary).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cannabis Discontinuation

    Behavioral

    Cannabis-using participants will participate in an orientation session with a clinician and asked to abstain from cannabis use for four weeks, using established procedures for abstinence monitoring and reinforcement.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Cannabis-UsingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Homeostatic Sleep Drive

Rate of slow wave activity dissipation, assessed by at-home EEG headband. Compared within person (cannabis-using days vs. non using days), between groups (Cannabis-Using, Control) at Baseline, and within-group (Cannabis-Using) between Baseline and Post-discontinuation.

Time frame
Baseline, 1 week
2

Circadian Photosensitivity

Light-Induced Melatonin Suppression. Melatonin levels on during a 60-minute light exposure will be compared to melatonin levels on a prior night under dim light conditions (when the dim light melatonin onset was assessed). The primary outcome will be % reduction in melatonin levels. Will be compared between groups (Cannabis-Using, Control) at Baseline and within-group (Cannabis-Using) between Baseline and Post-discontinuation.

Time frame
Discontinuation, 4 weeks
3

Retinal Responsivity

Retinal responsivity assessed via pupillometry (specifically the Post-Illumination Pupil Response; PIPR). Will be compared between groups (Cannabis-Using, Control) at Baseline and within group (Cannabis-Using.

Time frame
End of discontinuation, 4 weeks

Secondary outcomes

1

Circadian phase

Dim light melatonin onset (DLMO). Compared between groups (Cannabis-Using, Control) at Baseline, and within-group (Cannabis-Using) between Baseline and Post-discontinuation.

Time frame
End of discontinuation, 4 weeks

Other outcomes

Sponsors and contacts

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University of Pittsburgh

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator