NCT06982950

Brief Summary

The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
74mo left

Started Jul 2025

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jul 2025Jun 2032

First Submitted

Initial submission to the registry

May 3, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2032

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

5 years

First QC Date

May 3, 2025

Last Update Submit

May 13, 2025

Conditions

Keywords

Sleep, slow wavePolysomnographyMarijuana AbuseCannabinoidsEcological Momentary AssessmentSleep Duration

Outcome Measures

Primary Outcomes (3)

  • Daily Cannabis Use Frequency

    The number of smoking/vaping sessions per day.

    Assessed in surveys performed 4 times per day, and across the entire 21-day study

  • Wake After Sleep Onset (WASO)

    Wake after sleep onset (measured in minutes) will be assessed each night from actigraphy; larger value indicates greater disruptions to sleep.

    21 days

  • Cortisol Awakening Response

    Salivary cortisol levels assessed as the difference between waking and peak levels assessed \~30-45 minutes after awakening.

    8 nights

Secondary Outcomes (18)

  • Wake After Sleep Onset (Polysomnography)

    8 nights

  • Sleep Latency

    8 nights

  • Total Sleep Time

    up to 21 days

  • Sleep Macroarchitecture

    8 nights

  • Sleep Microarchitecture

    8 nights

  • +13 more secondary outcomes

Study Arms (2)

Sleep Restriction

EXPERIMENTAL

After a baseline assessment of sleep, participants in this arm will undergo 2 nights of restricted sleep (4 hour time in bed).

Other: Manipulation of Sleep Duration

Sleep Extension

EXPERIMENTAL

After a baseline assessment of sleep, participants in this arm will undergo 3 nights of an extended sleep opportunity (10 hour time in bed).

Other: Manipulation of Sleep Duration

Interventions

After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4 hour time in bed) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10 hour time in bed)

Sleep ExtensionSleep Restriction

Eligibility Criteria

Age21 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • fluent in English
  • \<BMI\<40 kg/m2
  • no shift work in the last 12 months
  • no travel across time zones in the last 2 months.

You may not qualify if:

  • Chronic disease-Medical history/prior diagnosis of the following:
  • cardiometabolic disease (e.g., myocardial infarction, angina, diabetes)
  • essential hypertension
  • hepatic impairment
  • severe obstructive sleep apnea
  • restless legs syndrome
  • parasomnia
  • neurological disease (e.g., early onset dementia)
  • unstable psychiatric disorders (e.g., bipolar disorder, schizophrenia, major depression with suicidality).
  • Drug/Alcohol use criteria:
  • Illicit drugs apart from cannabis or related products are prohibitive.
  • Volunteers may consume caffeine, however, \>3 cups of coffee (or otherwise equivalent of \>300mg/day) is prohibitive.
  • Participants who consume \>14 alcoholic drinks/week and/or have a diagnosis (or history) of alcohol use disorder will be excluded (a toxicological urine screen will be conducted to verify reported non-use during the initial screening and on the day of admission to the in-laboratory portion of the study).
  • Contraceptives are required for women and will continue to be taken throughout the experiment.
  • Prior Shift Work:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Nicole Bowles, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: After a baseline assessment of sleep, participants will undergo either 2 nights of restricted sleep (4h time in bed \[TIB\]) followed by a recovery sleep, OR 3 nights of an extended sleep opportunity (10h TIB)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant Professor

Study Record Dates

First Submitted

May 3, 2025

First Posted

May 21, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2032

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share