Biofeedback for Adolescent Cannabis Use Disorder

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02059083

Enrollment

Registered

2014-02-11

Start date

2014-09-30

Completion date

2014-09-30

Last updated

2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Cannabis Use Disorder

Keywords

adolescent, cannabis, biofeedback

Brief 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).

Interventions

BEHAVIORALHeart rate variability biofeedback

BEHAVIORALCBT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to 19 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Change in Perceived Stress Scale	baseline and 16 weeks

Secondary

Measure	Time frame
Change in the number of days used marijuana in the past 28 days	baseline and 16 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026