Back to resultsBiofeedback for Adolescent Cannabis Use Disorder
Primary Purpose
Adolescent Cannabis Use Disorder
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Heart rate variability biofeedback
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Cannabis Use Disorder focused on measuring adolescent, cannabis, biofeedback
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Cognitive behavioral therapy (CBT) alone
Cognitive behavioral therapy plus HRV biofeedback
Arm Description
Outcomes
Primary Outcome Measures
Change in Perceived Stress Scale
Secondary Outcome Measures
Change in the number of days used marijuana in the past 28 days
Full Information
NCT ID
NCT02059083
First Posted
February 5, 2014
Last Updated
April 28, 2015
Sponsor
Denver Health and Hospital Authority
1. Study Identification
Unique Protocol Identification Number
NCT02059083
Brief Title
Biofeedback for Adolescent Cannabis Use Disorder
Official Title
Biofeedback for Adolescent Cannabis Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not received; study was never started
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Cannabis Use Disorder
Keywords
adolescent, cannabis, biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy (CBT) alone
Arm Type
Active Comparator
Arm Title
Cognitive behavioral therapy plus HRV biofeedback
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Heart rate variability biofeedback
Intervention Type
Behavioral
Intervention Name(s)
CBT
Primary Outcome Measure Information:
Title
Change in Perceived Stress Scale
Time Frame
baseline and 16 weeks
Secondary Outcome Measure Information:
Title
Change in the number of days used marijuana in the past 28 days
Time Frame
baseline and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Thurstone, M.D.
Organizational Affiliation
Denver Health
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Biofeedback for Adolescent Cannabis Use Disorder
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