Changes in Cognition and Psychiatric Disorder Symptoms During Cannabis Abstinence Using a Novel Discordant Twin Design
1 other identifier
interventional
100
1 country
1
Brief Summary
This study will test whether 42 days of cannabis abstinence, compared to continued cannabis use, is associated with improvements in cognition and psychiatric disorder symptoms. Identical twins, who are concordant on cannabis use, will be experimentally-manipulated to be discordant for 42 days. Each twin, within a twin pair, will be randomly assigned to either the contingency management condition, incentive-based protocol to promote cannabis abstinence, or control condition, no changes in cannabis use requested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 16, 2021
CompletedStudy Start
First participant enrolled
May 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 12, 2026
February 1, 2026
2.9 years
November 19, 2021
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (9)
Change in attention performance
Flanker Inhibitory Control and Attention Test on NIH Toolbox: Composite score of accuracy and reaction time
Change from baseline to day 42
Change in episodic memory
Picture Sequence Memory Test on NIH Toolbox: Cumulative number of correct adjacent pairs
Change from baseline to day 42
Change in working memory
List Sorting Working Memory Test on NIH Toolbox: Total items correct across all trials
Change from baseline to day 42
Change in receptive vocabulary
Picture Vocabulary Test on NIH Toolbox: Computer adaptive testing
Change from baseline to day 42
Change in reading decoding
Oral Reading Recognition Test: Number of letters and words read correctly
Change from baseline to day 42
Change in immediate memory/verbal learning
Auditory Verbal Learning Test on NIH Toolbox: Total number of words recalled
Change from baseline to day 4
Change in pattern comparison processing speed
Pattern Comparison Processing Speed Test: Total number of correct responses
Change from baseline to day 42
Change in oral symbol digit test processing speed
Oral Symbol Digit Test on NIH Toolbox: Total number of correctly identified symbols
Change from baseline to day 42
Change in attention and executive function
Dimensional Change Card Sort Test on NIH Toolbox: Composite score of accuracy and correct answers
Change from baseline to day 42
Secondary Outcomes (3)
Change in anxiety symptoms
Change from baseline to day 42
Change in depressive symptoms
Change from baseline to day 42
Change in attention deficit/hyperactivity disorder symptoms
Change from baseline to day 42
Study Arms (2)
Contingency management
EXPERIMENTALContingency management (CM) is an incentive-based intervention providing patients with tangible rewards as reinforcement for positive behaviors like abstinence from drug use. Incentives are provided with each urine sample that is drug-free and are increased with each subsequent drug-free urine sample. Participants in the CM condition will receive increasing payments for abstinence: $30 on day 3, $45 on day 5, $60 on day 7, $75 on day 14, $90 on day 21, $105 on day 28, and $120 on day 42. Participants in both conditions also receive increasing payment for visit attendance: $10 on day 1, $15 on day 3, $20 on day 5, $25 on day 7, $30 on day 14, $35 on day 21, $45 on day 28, and $55 on day 42. At the end of the baseline visit, participants in the CM condition will sign a behavioral contract with study staff that clearly outlines expectations as well as the payment schedule.
No intervention
NO INTERVENTIONParticipants in this condition will be monitored and will not receive any compensation for cannabis abstinence.
Interventions
Participants will be paid to abstain from cannabis use.
Eligibility Criteria
You may qualify if:
- Monozygotic (MZ) twin pair, in which both twins are willing to participate
- MZ twin pair must be concordant in their frequency of cannabis use (+/- 2 days)
- Cannabis use at least 1x per week on most weeks
- Cannabis use in the past 7 days at the baseline visit
- Positive qualitative urine toxicology at baseline for THC
- Located within the state of Colorado
You may not qualify if:
- \) Discordance in the twin pairs on a significant, adverse experience, like traumatic brain injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of Colorado, Bouldercollaborator
Study Sites (1)
Jessica M Ross
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J. Megan Ross, Ph.D.
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2021
First Posted
December 16, 2021
Study Start
May 5, 2023
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
In accordance with NIH data sharing policies, data produced from this project will be made available to ensure timely translation of research results to improve human health. The investigators believe there is a possibility of deductive disclosure of subjects with unusual characteristics, even though all identifiers would be removed prior to release for sharing. Thus, the investigators will make the data and associated documentation available to users only under a specific data-sharing agreement that requires: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.