Substance AbusePhase 1ADAPTNCT00680576
Adolescent Substance Abuse: Progressive Treatment
A Phase 1 study testing CBT, Cognitive Behavioral Therapy and FFT, Family Functional Therapy in people with Substance Abuse, run by Oregon Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to find out more about how to provide effective further treatment for adolescents who have received six weeks of group therapy for substance-use problems and continue to use drugs. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- CBT, Cognitive Behavioral Therapy and FFT, Family Functional Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2013
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13 to 18 years if age
- Meet DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
- Live in the Albuquerque metropolitan area or surrounding communities
- Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).
Who cannot join
- There is evidence of psychotic or organic state of sufficient severity to interfere with the understanding of study instruments and procedures
- The adolescent is deemed dangerous to self or others during evaluation
- Services other than outpatient treatment are required for the adolescent (e.g., inpatient, detoxification)
- Marijuana use is reported as being less than 13% of days in the previous 90 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)
Albuquerque, New Mexico, 87102
About this study
The purpose of this study is to find out more about how to provide effective further treatment for adolescents who have received six weeks of group therapy for substance-use problems and continue to use drugs. Treatments used in the study include a group therapy (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at whether abstinence or a very low level of use is a better guide for deciding whether further treatment is needed, how well different combinations of treatment work to reduce substance use, and whether it is possible to predict in advance which adolescents will respond best to which types of treatment. Study investigators expect that a treatment strategy using what is learned about these issues in the first half of the project to develop an "adaptive" treatment model will work better than a "fixed" treatment to reduce adolescent substance use.
- Conditions
- Substance Abuse
- Being tested
- CBT, Cognitive Behavioral Therapy, FFT, Family Functional Therapy
- Keywords
- adolescent substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT, Cognitive Behavioral TherapyBehavioural
Eight weekly sessions of individual Cognitive Behavioral Therapy, to develop skills enabling adolescents stop or reduce their drug use.
FFT, Family Functional TherapyBehavioural
Eight weekly sessions of Functional Family Therapy designed to strengthen family relationships and build skills to help the adolescent stop or reduce his/her drug use.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Eight weeks of individual CBT for adolescents who have completed six weeks of group therapy and continue to use drugs. Receives: Behavioral: CBT, Cognitive Behavioral Therapy |
| 2 | Active comparator | Eight weeks of FFT for adolescents who have received six weeks of group therapy and continue to use drugs. Receives: Behavioral: FFT, Family Functional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine drug screens
Measured: Pretx, 6, 14 and 22 weeks, 3 and 6 months after initial treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly B Waldron, Ph.D., Principal investigator, Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680576
- Sponsor's protocol ID
- DA023568
- Other IDs
- R01DA023568
- Acronym
- ADAPT
- Status last verified
- Oct 2014
- First submitted
- 16 May 2008
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Substance Abuse: Progressive Treatment
- ClinicalTrials.gov ID
- NCT00680576
- Acronym / sponsor ID
- ADAPT / DA023568
- Conditions
- Substance Abuse
- Keywords
- adolescent substance abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 May 2008 (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 find out more about how to provide effective further treatment for adolescents who have received six weeks of group therapy for substance-use problems and continue to use drugs. Treatments used in the study include a group therapy (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at whether abstinence or a very low level of use is a better guide for deciding whether further treatment is needed, how well different combinations of treatment work to reduce substance use, and whether it is possible to predict in advance which adolescents will respond best to which types of treatment. Study investigators expect that a treatment strategy using what is learned about these issues in the first half of the project to develop an "adaptive" treatment model will work better than a "fixed" treatment to reduce adolescent substance use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: CBT, Cognitive Behavioral TherapyEight weeks of individual CBT for adolescents who have completed six weeks of group therapy and continue to use drugs. |
| 2 | Active comparator | Behavioral: FFT, Family Functional TherapyEight weeks of FFT for adolescents who have received six weeks of group therapy and continue to use drugs. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 13 to 18 years if age
- Meet DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
- Live in the Albuquerque metropolitan area or surrounding communities
- Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).
Key exclusion criteria (4 listed)
- There is evidence of psychotic or organic state of sufficient severity to interfere with the understanding of study instruments and procedures
- The adolescent is deemed dangerous to self or others during evaluation
- Services other than outpatient treatment are required for the adolescent (e.g., inpatient, detoxification)
- Marijuana use is reported as being less than 13% of days in the previous 90 days.
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 |
|---|---|---|
| CBT, Cognitive Behavioral TherapyEight weekly sessions of individual Cognitive Behavioral Therapy, to develop skills enabling adolescents stop or reduce their drug use. | Behavioural | 1 |
| FFT, Family Functional TherapyEight weekly sessions of Functional Family Therapy designed to strengthen family relationships and build skills to help the adolescent stop or reduce his/her drug use. | Behavioural | 2 |
Primary outcome
Urine drug screens
Time frame: Pretx, 6, 14 and 22 weeks, 3 and 6 months after initial treatment session
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 10 Oct 2014.
Related trials for Substance Abuse
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Enrolling by invitation
MIO-CPP to Improve the Well-being, Permanency, and Safety Outcomes for Young Children at Risk of or in Out-of-home Placement in Philadelphia and Bucks Counties, and Affected by Maternal Substance Use
Substance Use Disorders, Parent-Child Relations
RecruitingObservational study
Cannabis Abstinence and Neurocognitive Assessment in Adolescence
Cannabis Dependence, Harmful Use
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.
Holly B Waldron, Ph.D. principal investigator
Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT, Cognitive Behavioral Therapy and FFT, Family Functional Therapy in people with Substance Abuse, run by Oregon Research Institute 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 4 inclusion and 4 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 10 Oct 2014. 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.
What does this 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.
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 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?
Urine drug screens (time frame: Pretx, 6, 14 and 22 weeks, 3 and 6 months after initial treatment session). 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 10 Oct 2014.