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Determining the Effect of Six Weeks of Cannabis Abstinence on Fronto- Striatal fMRI Markers in Adolescents With Cannabis Use Disorder (ABSCAN)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to understand the changes in neural correlates of reward in adolescents with and without Cannabis Use Disorder (CUD). The study will collect functional magnetic resonance imaging (fMRI) data at 3 different timepoints with the primary goals of understanding striatal reward-based activation during a Monetary Incentive Delay Task and fronto-striatal fMRI resting-state functional connectivity. The study will also explore self-reported impulsivity. The long-term goal is to advance scientific understanding of neural changes associated with cannabis abstinence and inter-individual variability that cannot be otherwise measured in preexisting observational cohorts such as the Adolescent Brain Cognitive Development Study. This parallel intervention study will collect fMRI data in adolescents ages 15-18 years old with and without CUD at three different timepoints over the course of their intervention. Utilizing a validated paradigm, adolescents with CUD will be randomized to 6-weeks of either incentivized, biochemically verified abstinence via contingency management or monitoring with no required abstinence. Age- and sex-matched adolescents with no lifetime history of cannabis use will also complete the protocol. Participants will complete 8 study visits (3 with fMRI scans) involving urinalysis to confirm cannabis self-report and measures of impulsivity. Participants may additionally and optionally (1) complete daily remote self-report assessments of cannabis use, impulsivity, and mood throughout the 6-week treatment period, and (2) continue participation for an additional 6-week monitoring period after the treatment period, during which they complete daily remote self-report assessments of cannabis use, impulsivity, and mood.

Official Title

Determining the Effect of Six Weeks of Cannabis Abstinence on Fronto- Striatal fMRI Markers in Adolescents With Cannabis Use Disorder (ABSCAN)

Quick Facts

Study Start:2024-04-01

Study Completion:2028-04-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06124846

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Male and female adolescents between the ages of 15 and 18 (inclusive). * Have a parent or legal guardian who is able and willing to provide written informed consent. * Competent and willing to provide written informed assent (participants \<18) or consent (participants=18). * Native English speaker. * Have a parent or legal guardian who is fluent in English. * Able to commit to 8 study visits in approximately 60 days (6 weeks). * Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the PI. * No active psychosis or current use of antipsychotic medications. * Participants taking psychotropic medications will be included if the medications have been stable for 6 weeks and are expected to remain stable for the duration of their study participation (i.e., through the third MRI). * For CB-Abst (n=24) and CB-Mon (n=20) groups: at least 5 days of use per week on average in the past two months and meet DSM-V cannabis use disorder (CUD; at least Mild) criteria. Cannabis use reported within seven days of baseline visit. Positive qualitative urine toxicology test at baseline for THC. No immediate plan to discontinue cannabis use. * For Con (n=20): no lifetime history of cannabis use. Negative qualitative urine toxicology test at baseline for THC. No immediate plans to begin cannabis use. * For optional components (A: daily remote assessments during and/or (B) after treatment period): access to a personal device (e.g., smartphone or computer) on which to complete daily remote assessments.	* Past twelve-month history of substance use disorders (except for Cannabis Use Disorder in CB-Abst and CB-Mon), assessed via semi-structured psychodiagnostics interview at baseline. * Current daily nicotine use (e.g., via electronic and/or combustible cigarettes). * Contraindications for MRI (ascertained via participant and parent report), including but not limited to: 1. Metal implants such as surgical clips or pacemakers, or history of working with metal, unless the possibility of a metal fragment can be ruled out by recent orbital scans. 2. Prior head trauma with neurological sequelae. 3. Claustrophobia. 4. Weight incompatible with MRI safety. 5. Pregnancy. * Previous or current diagnosis of psychosis, cognitive disability, or bipolar disorder. * Active suicidality. * Taking a psychotropic medication that has not reached stability criterion (same medication type and dose for 6 weeks with no planned changes over the study period). * Any other medical or psychiatric condition deemed serious or contraindicated for any study procedures by Dr. Tervo-Clemmens.

Inclusion Criteria

Exclusion Criteria

* Male and female adolescents between the ages of 15 and 18 (inclusive).
* Have a parent or legal guardian who is able and willing to provide written informed consent.
* Competent and willing to provide written informed assent (participants \<18) or consent (participants=18).
* Native English speaker.
* Have a parent or legal guardian who is fluent in English.
* Able to commit to 8 study visits in approximately 60 days (6 weeks).
* Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the PI.
* No active psychosis or current use of antipsychotic medications.
* Participants taking psychotropic medications will be included if the medications have been stable for 6 weeks and are expected to remain stable for the duration of their study participation (i.e., through the third MRI).
* For CB-Abst (n=24) and CB-Mon (n=20) groups: at least 5 days of use per week on average in the past two months and meet DSM-V cannabis use disorder (CUD; at least Mild) criteria. Cannabis use reported within seven days of baseline visit. Positive qualitative urine toxicology test at baseline for THC. No immediate plan to discontinue cannabis use.
* For Con (n=20): no lifetime history of cannabis use. Negative qualitative urine toxicology test at baseline for THC. No immediate plans to begin cannabis use.
* For optional components (A: daily remote assessments during and/or (B) after treatment period): access to a personal device (e.g., smartphone or computer) on which to complete daily remote assessments.

* Past twelve-month history of substance use disorders (except for Cannabis Use Disorder in CB-Abst and CB-Mon), assessed via semi-structured psychodiagnostics interview at baseline.
* Current daily nicotine use (e.g., via electronic and/or combustible cigarettes).
* Contraindications for MRI (ascertained via participant and parent report), including but not limited to:
1. Metal implants such as surgical clips or pacemakers, or history of working with metal, unless the possibility of a metal fragment can be ruled out by recent orbital scans.
2. Prior head trauma with neurological sequelae.
3. Claustrophobia.
4. Weight incompatible with MRI safety.
5. Pregnancy.
* Previous or current diagnosis of psychosis, cognitive disability, or bipolar disorder.
* Active suicidality.
* Taking a psychotropic medication that has not reached stability criterion (same medication type and dose for 6 weeks with no planned changes over the study period).
* Any other medical or psychiatric condition deemed serious or contraindicated for any study procedures by Dr. Tervo-Clemmens.

Contacts and Locations

Study Contact

Venessa Fuentes

CONTACT

tclab@umn.edu

Principal Investigator

Brenden Tervo-Clemmens, PhD

PRINCIPAL_INVESTIGATOR

University of Minnesota

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55414

United States

Collaborators and Investigators

Sponsor: University of Minnesota

Brenden Tervo-Clemmens, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2028-04-15

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2028-04-15

Terms related to this study

Additional Relevant MeSH Terms

Cannabis Use Disorder