Mental DisordersNCT01656707
Adaptive Treatment for Adolescent Cannabis Use Disorders
A study testing ACRA and CBT in people with Mental Disorders and Addictive Behaviors, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Mental Disorders, Addictive Behaviors, Cannabis Use Disorder
- What is being tested?
- ACRA and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2016
- Phase
- Interventional
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 13-18 years of age at the time of intake assessment
- Current diagnosis of DSM-IV Cannabis Abuse or Dependence
- Able to read and comprehend English at a 5th grade level
- Residence within 45 minutes drive from the UCHC Farmington treatment site
- Participant and a parent/legal guardian responsible for providing collateral information agree to sign an IRB approved consent form
- Participant and a parent/legal guardian responsible for providing collateral information agree to provide locator information
- The family is not planning to move from the area during the next six months
Who cannot join
- Meet criteria for dependence of any other substance of abuse other than nicotine or alcohol
- Report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days
- Meet a lifetime diagnosis of schizophrenia
- Has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment
- Demonstrate an inability or unwillingness to provide locator information
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030-2103
About this study
The purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.
Read the detailed description
The study will address the current contrasts in youth response to treatment, the problem of poor response to treatment and the prevention of relapse. Results from the study may support Adaptive Treatment as an efficacious approach for youth with Cannabis Use Disorder who are poor responders to treatment.
Poor responders fall into two categories, those who failed to achieve a negative drug urinalysis during the last session of the initial MET/CBT-7 treatment they attended, and those who either dropped out or were administratively discharged at any time during the initial MET/CBT-7 treatment.
- Conditions
- Mental Disorders, Addictive Behaviors, Cannabis Use Disorder
- Being tested
- ACRA, CBT
- Keywords
- Adolescents, Substance Use Disorders
- Medical subject headings
- Mental Disorders, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRABehavioural
Also called Adolescent Community Reinforcement Approach
Ten weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian).
CBTBehavioural
Also called Cogntive Behavioral Therapy
10 weekly, 60-minute sessions of augmented individualized CBT
| Study group | Role | What they receive |
|---|---|---|
| ACRA | Experimental | Ten weekly 60-minute sessions of Adolescent Community Reinforcement Approach (ACRA) will be provided as an Adaptive treatment condition. Receives: Behavioral: ACRA |
| Cognitive Behavioral Therapy (CBT) | Experimental | Ten weekly, 60-minute sessions of augmented individualized Cognitive Behavioral Therapy (CBT)will be provided as an Adaptive Treatment condition Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.) To evaluate the efficacy of AT for youth who have been defined as poor responders to an evidence-based practice intervention such as the initial MET/CBT-7.
Each participant will serve as his/her own control. The outcomes will include the T-ASI, T-ASI-P, and drug urinalyses.
Measured: one year
Secondary outcomes (1)
To assess outcomes as a function of mediator variables such as self-efficacy, coping skills, readiness to change, and environmental support (i.e., family and peer), within each of the AT interventions.
The secondary outcome measures will include the SCQ, CRI, PRQ, and SSQ.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Yifrah Kaminer, MD, MBA, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656707
- Sponsor's protocol ID
- PA08-263
- Other IDs
- R01DA030454
- Status last verified
- Apr 2017
- First submitted
- 1 Aug 2012
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Treatment for Adolescent Cannabis Use Disorders
- ClinicalTrials.gov ID
- NCT01656707
- Acronym / sponsor ID
- PA08-263
- Conditions
- Mental Disorders, Addictive Behaviors, Cannabis Use Disorder
- Keywords
- Adolescents, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Aug 2012 (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 purpose of this study is to examine an Adaptive Treatment approach in order to improve outcomes of youth with Cannabis Use Disorders who are poor responders to treatment.
Detailed description
The study will address the current contrasts in youth response to treatment, the problem of poor response to treatment and the prevention of relapse. Results from the study may support Adaptive Treatment as an efficacious approach for youth with Cannabis Use Disorder who are poor responders to treatment.
Poor responders fall into two categories, those who failed to achieve a negative drug urinalysis during the last session of the initial MET/CBT-7 treatment they attended, and those who either dropped out or were administratively discharged at any time during the initial MET/CBT-7 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACRA | Experimental | Behavioral: ACRATen weekly 60-minute sessions of Adolescent Community Reinforcement Approach (ACRA) will be provided as an Adaptive treatment condition. |
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: CBTTen weekly, 60-minute sessions of augmented individualized Cognitive Behavioral Therapy (CBT)will be provided as an Adaptive Treatment condition |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 13-18 years of age at the time of intake assessment
- Current diagnosis of DSM-IV Cannabis Abuse or Dependence
- Able to read and comprehend English at a 5th grade level
- Residence within 45 minutes drive from the UCHC Farmington treatment site
- Participant and a parent/legal guardian responsible for providing collateral information agree to sign an IRB approved consent form
Key exclusion criteria (5 listed)
- Meet criteria for dependence of any other substance of abuse other than nicotine or alcohol
- Report suicidal ideation with a plan, suicidal behavior, a plan to hurt oneself or other, or a history of self-injurious behavior all occurring in the last 30 days
- Meet a lifetime diagnosis of schizophrenia
- Has any current health (i.e. medical, psychiatric) condition that will compromise the participant's ability to regularly attend treatment
- Demonstrate an inability or unwillingness to provide locator information
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 |
|---|---|---|
| ACRAAlso: Adolescent Community Reinforcement ApproachTen weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian). | Behavioural | ACRA |
| CBTAlso: Cogntive Behavioral Therapy10 weekly, 60-minute sessions of augmented individualized CBT | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
1.) To evaluate the efficacy of AT for youth who have been defined as poor responders to an evidence-based practice intervention such as the initial MET/CBT-7.
Time frame: one year
Each participant will serve as his/her own control. The outcomes will include the T-ASI, T-ASI-P, and drug urinalyses.
1 secondary outcome
To assess outcomes as a function of mediator variables such as self-efficacy, coping skills, readiness to change, and environmental support (i.e., family and peer), within each of the AT interventions.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Yifrah Kaminer, MD, MBA principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACRA and CBT in people with Mental Disorders and Addictive Behaviors, run by UConn Health at 1 site in United States.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1.) To evaluate the efficacy of AT for youth who have been defined as poor responders to an evidence-based practice intervention such as the initial MET/CBT-7. (time frame: one year). 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 11 Apr 2017.