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Changes in Cognition and Psychiatric Disorder Symptoms During Cannabis Abstinence Using a Novel Discordant Twin Design

Changes in Cognition and Psychiatric Disorder Symptoms During Cannabis Abstinence Using a Novel Discordant Twin Design

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05160688
Enrollment
146
Registered
2021-12-16
Start date
2023-05-05
Completion date
2026-03-23
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis

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.

Detailed description

The proposed project is a randomized controlled trial to compare cognition and psychiatric disorder symptoms between monozygotic (MZ) twin pairs, who are concordant on frequency of cannabis use. Each twin, within the twin pair, will be randomly assigned to either contingency management (CM), monetary incentives provided to reinforce cannabis abstinence, or control, no changes in cannabis use required or reinforced. Participants in the CM condition will receive an increasing schedule of payments at each visit reinforcing continued cannabis abstinence. All participants will receive increases in the payment schedule for attendance of each subsequent assessment. Participants will be assessed on measures of cognition including attention, memory, and processing speed as well as anxiety, depression, and ADHD symptoms. In addition, at each visit participants will complete a qualitative and quantitative drug test. The qualitative drug test will be used to determine if new cannabis use has occurred since the last visit, and will determine if the participant receives payment for abstinence. The investigators will also use previously collected genotype for each participant. The first aim of this study is to characterize cognitive recovery, across all potential cognitive domains, using an experimental manipulation to achieve discordance between MZ twins on cannabis use. The hypothesis for the first aim is that the abstinent group will have greater improvements in memory and processing speed compared to controls. However, there will not be any group differences between the abstinent group and the control group on attention, language, and executive function performance. The second aim of the proposed project is to characterize psychiatric disorder symptoms by comparing psychiatric disorder symptom changes among the cannabis abstaining twin to their cannabis using co-twin across 42 days. The abstinent group will endorse more psychiatric symptoms during the withdrawal period (up to 14 days) but will endorse fewer psychiatric symptoms at day 28 and 42 compared to the control group. The third aim (exploratory) of the proposed project is to examine how genetic risk for psychiatric disorders interacts with environment (i.e., cannabis abstinence versus continued use) to influence cognitive functioning. The hypothesis for aim 3 is that anxiety, depression, and ADHD polygenic scores will be more strongly associated with cognitive outcomes in the control group compared to the abstinent group.

Interventions

BEHAVIORALContingency management

Participants will be paid to abstain from cannabis use.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
University of Colorado, Boulder
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
31 Years to 47 Years
Healthy volunteers
Yes

Inclusion criteria

1. Monozygotic (MZ) twin pair, in which both twins are willing to participate 2. MZ twin pair must be concordant in their frequency of cannabis use (+/- 2 days) 3. Cannabis use at least 1x per week on most weeks 4. Cannabis use in the past 7 days at the baseline visit 5. Positive qualitative urine toxicology at baseline for THC 6. Located within the state of Colorado

Exclusion criteria

1\) Discordance in the twin pairs on a significant, adverse experience, like traumatic brain injury.

Design outcomes

Primary

MeasureTime frameDescription
Change in attention performanceChange from baseline to day 42Flanker Inhibitory Control and Attention Test on NIH Toolbox: Composite score of accuracy and reaction time
Change in episodic memoryChange from baseline to day 42Picture Sequence Memory Test on NIH Toolbox: Cumulative number of correct adjacent pairs
Change in working memoryChange from baseline to day 42List Sorting Working Memory Test on NIH Toolbox: Total items correct across all trials
Change in receptive vocabularyChange from baseline to day 42Picture Vocabulary Test on NIH Toolbox: Computer adaptive testing
Change in reading decodingChange from baseline to day 42Oral Reading Recognition Test: Number of letters and words read correctly
Change in immediate memory/verbal learningChange from baseline to day 4Auditory Verbal Learning Test on NIH Toolbox: Total number of words recalled
Change in pattern comparison processing speedChange from baseline to day 42Pattern Comparison Processing Speed Test: Total number of correct responses
Change in oral symbol digit test processing speedChange from baseline to day 42Oral Symbol Digit Test on NIH Toolbox: Total number of correctly identified symbols
Change in attention and executive functionChange from baseline to day 42Dimensional Change Card Sort Test on NIH Toolbox: Composite score of accuracy and correct answers

Secondary

MeasureTime frameDescription
Change in anxiety symptomsChange from baseline to day 42Beck Anxiety Inventory: Total score. Scores range from 0-63 and higher scores indicate higher levels of anxiety.
Change in depressive symptomsChange from baseline to day 42Beck Depression Inventory: Total score. Scores range from 0-63 and higher scores indicate greater levels of depression.
Change in attention deficit/hyperactivity disorder symptomsChange from baseline to day 42Adult Self-Report Scale: Total score. Scores range from 0-72 and higher scores indicate greater level of symptoms of attention deficit/hyperactivity disorder.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJ. Megan Ross, Ph.D.

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026