MedDataX Logo

Biofeedback for Adolescent Cannabis Use Disorder

NCT ID: NCT02059083

Last Updated: 2015-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aims of this study are: 1) to estimate the effect size of HRV biofeedback for stress in adolescents undergoing cognitive behavioral therapy (CBT) for cannabis use disorder (primary outcome: Perceived Stress Scale) and 2) to estimate the effect size of HRV biofeedback for cannabis use in adolescents undergoing CBT for cannabis use disorder (primary outcome: number of days used cannabis in the past 30 days).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adolescent Cannabis Use Disorder

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

adolescent cannabis biofeedback

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive behavioral therapy (CBT) alone

Group Type ACTIVE_COMPARATOR

CBT

Intervention Type BEHAVIORAL

Cognitive behavioral therapy plus HRV biofeedback

Group Type EXPERIMENTAL

Heart rate variability biofeedback

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Heart rate variability biofeedback

Intervention Type BEHAVIORAL

CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* be between the ages of 13 and 19 years, with a parent or legal guardian available to complete parental assessments, if the participant is a minor
* meet Diagnostic and Statistical Manual of Mental Disorders, 5th edition, (DSM-V) criteria for cannabis use disorder by clinical interview;
* be medically healthy;
* be willing to participate in the study intervention and assessments;
* plan to live locally for at least 4 months;
* be able to read English well enough to complete study questionnaires;
* have self-reported cannabis use in the past 28 days;
* have a Perceived Stress Scale score \> 20.

Exclusion Criteria

* current or past psychosis;
* bipolar I or II disorder;
* the need to take psychotropic medications at any time during the study;
* pregnancy;
* psychiatric or substance use disorder that cannot be managed with outpatient care (e.g. alcohol withdrawal, severe major depressive disorder, significant suicidal ideation); and
* medications known to affect HRV (e.g. albuterol, pseudoephedrine, beta adrenergic blockers).
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Denver Health and Hospital Authority

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Thurstone, M.D.

Role: PRINCIPAL_INVESTIGATOR

Denver Health

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-0412

Identifier Type: -

Identifier Source: org_study_id