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Recruiting NCT07340554

Neuroimaging of Adolescent Cannabis Use Treatment

No phase Interventional Cannabis Use Cannabis Dependence Cannabis Use Disorder Cannabis Abuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contingency Management, Elastic Net Regression.
Who it may be relevant to
Registry conditions: Cannabis Use, Cannabis Dependence, Cannabis Use Disorder, Cannabis Abuse. Basic parameters: 14 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Neuroimaging of Instrumental Learning Networks in Adolescent Cannabis Use Treatment

Overview

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.

Detailed 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 (CM) 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).

Interventions

  • Behavioral Contingency Management
    Contingency management is an evidence-based behavioral intervention used to treat substance use disorders, including cannabis use disorder (CUD). Contingency management operates on the principles of instrumental learning, where positive reinforcement is used to encourage desired behaviors, such as abstinence from cannabis. First, specific target behaviors are identified for reinforcement. In CUD, this is often abstinence from cannabis use, verified through regular urine drug screens and self-rep
  • Device Elastic Net Regression
    We will apply an elastic net regression model to the neuroimaging data to estimate CUDIT score based on neuroimaging data.

Primary outcome measures

  • Cannabis use frequency [Time frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
  • Cannabis Use Disorder Identification Test (CUDIT) Score [Time frame: Baseline]
Secondary outcome measures (4)
  • Total quantity of cannabis use [Time frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
  • Cannabis withdrawal [Time frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
  • Cannabis expectancy [Time frame: Screening and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]
  • Proportion of negative cannabis urine drug screen [Time frame: Screening, Baseline, once weekly at each CM visit, and Post-Intervention Follow-Up Visit (2-4 weeks after last CM visit)]

Eligibility criteria

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 OR youth must have been diagnosed with cannabis use disorder within the past three months

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Indiana University School of Medicine — Indianapolis

Identifiers

NCT: NCT07340554 · 27183 · K23DA063832

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗