NCT05160688

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

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

November 19, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

November 19, 2021

Last Update Submit

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

EXPERIMENTAL

Contingency 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.

Behavioral: Contingency management

No intervention

NO INTERVENTION

Participants 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.

Contingency management

Eligibility Criteria

Age31 Years - 47 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Jessica M Ross

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • J. Megan Ross, Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

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.

Locations