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Neuroimaging of Adolescent Cannabis Use Treatment (ACT)

Indiana University logo

Indiana University

Status

Enrolling

Conditions

Cannabis Withdrawal
Marijuana Dependence
Substance Use
Marijuana-Related Disorder
Cannabis Abuse, Episodic Use
Cannabis-Related Disorder
Substance Related Problem
Cannabis Dependence
Cannabis Use Disorder
Marijuana Use
Substance Use Disorders
Cannabis Use
Cannabis Smoking
Substance Abuse
Marijuana Smoking
Marijuana
Substance Abuse Drug Chronic
Cannabis Abuse, in Remission
Cannabis Intoxication
Marijuana User
Marijuana Abuse
Addiction, Substance
Cannabis Abuse
Addiction
Marijuana Use Disorder
Substance Dependence

Treatments

Behavioral: Contingency Management
Device: Elastic Net Regression

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07340554
K23DA063832 (U.S. NIH Grant/Contract)
27183

Details and patient eligibility

About

This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.

Full description

This is a 13-week clinical trial to examine whether success during contingency management treatment for cannabis use is associated with baseline functioning of instrumental learning neuro-circuitries. The investigators propose to recruit N=80 youths ages 14-17 with varying levels of cannabis use. Following phone prescreening, participants will undergo informed consent/assent and eligibility assessment with an in-person visit. Participants who are eligible will undergo a functional magnetic resonance imaging (fMRI) scan where participants will perform an instrumental learning task during a second in-person visit. At this visit, participants and participants' guardians or most recent caregiver will be provided with ten urine drug screens. A tutorial will be provided by study staff on how to administer and read urine drug screens. After the fMRI scan, participants will undergo ten weekly virtual contingency management sessions administered via HIPAA-compliant telehealth software (e.g., Microsoft Teams). At each contingency management session, participants will be asked to provide a urine sample, and participants' guardians will be asked to administer the urine drug screen based on this sample. At each contingency management session, the timeline followback will be used to assess which days since the last session participants used cannabis at all. Finally, at each contingency management session, participants will answer brief questionnaires regarding participants' current cannabis cravings and cannabis withdrawal symptoms. For the first two sessions, participants will be able to spin a virtual wheel to win prizes (either positive affirmations or amazon gift cards in varying amounts from $5-$100) for producing a urine drug screen and answering the questions. For sessions 3-10, participants will spin the virtual wheel to win prizes after producing a urine drug screen that is negative for cannabinoids and reporting that they have not used cannabis since the last session. After the ten weekly contingency management sessions, participants will return for an in-person visit where participants will answer questions regarding their cannabis use disorder symptoms during the contingency management treatment and readiness to change. The investigators' specific aims are to identify associations between baseline Cannabis Use Disorder (CUD) symptom levels and neural activity during instrumental learning in cannabis-using adolescents (Aim 1) and Identify associations between neural activity during instrumental learning and reductions in cannabis use frequency during contingency management (Aim 2).

Enrollment

80 estimated patients

Sex

All

Ages

14 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 14-17 year old youth
  • Guardian 18 years or older
  • Youth is MRI-eligible: No metal implants, prosthetics, orthodontic devices, transdermal medication patches, piercings and/or hair or eyelash extensions that cannot easily be removed, metallic ink tattoos on the neck or face, or claustrophobia, and are not pregnant
  • Youth must endorse having used cannabis at least once per week over the past month

Exclusion criteria

  • Youth has a history of Fetal Alcohol Spectrum Disorder, intellectual disorders, pervasive development disorder or autism spectrum disorder, psychotic disorders, history of neurological problems (epilepsy, traumatic brain injury, brain tumor, cerebrovascular disease) by parent/guardian report
  • Youth or caretaker who is monolingual non-English speaker
  • Youth who is currently experiencing active psychosis symptoms or suicidal/homicidal ideation or who has been hospitalized within the past 6 months for psychosis or suicidality/homicidality
  • Youth who is currently undergoing contingency management treatment for cannabis use disorder

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Contingency Management and Elastic Net Regression
Other group
Description:
All participants will receive Contingency Management treatment for Cannabis Use. An elastic net regression model will be applied to the neuroimaging data for all participants to estimate scores on the CUDIT.
Treatment:
Device: Elastic Net Regression
Behavioral: Contingency Management

Trial contacts and locations

1

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Central trial contact

Katherine LeFevre, BS; Joseph Aloi, MD, PhD

Data sourced from clinicaltrials.gov

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