Biofeedback for Adolescent Cannabis Use Disorder

Adolescent Cannabis Use Disorder Clinical Trial

Official title:

Biofeedback for Adolescent Cannabis Use Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02059083
• Other study ID #: 13-0412
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: February 5, 2014
• Last updated: April 28, 2015
• Start date: September 2014
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Cannabis Use Disorder
• Marijuana Abuse

Intervention

Behavioral:
• Heart rate variability biofeedback

• CBT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perceived Stress Scale		baseline and 16 weeks	No
Secondary	Change in the number of days used marijuana in the past 28 days		baseline and 16 weeks	No