Adolescent Cannabis Use DisorderPhase 1/2NCT02059083
Biofeedback for Adolescent Cannabis Use Disorder
A Phase 1/2 study testing Heart rate variability biofeedback and CBT in people with Adolescent Cannabis Use Disorder, run by Denver Health and Hospital Authority.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Adolescent Cannabis Use Disorder
- What is being tested?
- Heart rate variability biofeedback and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
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).
- Conditions
- Adolescent Cannabis Use Disorder
- Being tested
- Heart rate variability biofeedback, CBT
- Keywords
- adolescent, cannabis, biofeedback
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedbackBehavioural
CBTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy (CBT) alone | Active comparator | Not described Receives: Behavioral: CBT |
| Cognitive behavioral therapy plus HRV biofeedback | Experimental | Not described Receives: Behavioral: Heart rate variability biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale
Measured: baseline and 16 weeks
Secondary outcomes (1)
Change in the number of days used marijuana in the past 28 days
Measured: baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Funding not received; study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Thurstone, M.D., Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059083
- Sponsor's protocol ID
- 13-0412
- Status last verified
- Apr 2015
- First submitted
- 5 Feb 2014
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback for Adolescent Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT02059083
- Acronym / sponsor ID
- 13-0412
- Conditions
- Adolescent Cannabis Use Disorder
- Keywords
- adolescent, cannabis, biofeedback
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not received; study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy (CBT) alone | Active comparator | Behavioral: CBT |
| Cognitive behavioral therapy plus HRV biofeedback | Experimental | Behavioral: Heart rate variability biofeedback |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedback | Behavioural | Cognitive behavioral therapy plus HRV biofeedback |
| CBT | Behavioural | Cognitive behavioral therapy (CBT) alone |
Primary outcome
Change in Perceived Stress Scale
Time frame: baseline and 16 weeks
1 secondary outcome
Change in the number of days used marijuana in the past 28 days
Time frame: baseline and 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Substance Use Screening to Encourage Behavior Change Among Young People in Primary Care
Substance Use, Binge Drinking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Thurstone, M.D. principal investigator
Denver Health
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Heart rate variability biofeedback and CBT in people with Adolescent Cannabis Use Disorder, run by Denver Health and Hospital Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (time frame: baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.