Behavior and Mental DisordersPhase 1AIMSNCT00680511

Development of a Family-Based Treatment for Adolescent Methamphetamine Use

A Phase 1 study testing Adolescent Methamphetamine Treament (AMT) and Functional Family Therapy (FFT) in people with Behavior and Mental Disorders and Methamphetamine Disorders, run by Oregon Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Behavior and Mental Disorders, Methamphetamine Disorders
What is being tested?: Adolescent Methamphetamine Treament (AMT) and Functional Family Therapy (FFT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Sep 2007to Dec 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 15 to 19 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

15 to 19 years of age.
Have at least one parent or parent figure willing to participate.
Meet DSM-IV diagnostic criteria for drug-abuse or dependence, including a specific meth use disorder.
Reports meth use on at least 5 of the previous 90 days.
Have contact with the parent on at least 40% of the past 90 days.
With their parent be willing to accept randomization to one of the two treatment interventions.

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Be willing to participate in the imaging task in the fMRI pilot study.
Have basic English competency.
Have sufficient residential stability to permit probable contact at follow-up.

Who cannot join

Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
Have a medical or psychological condition that would preclude undergoing the fMRI scan.
Have a sibling who is participating in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Research Institute Center for Family and Adolescent Research
Portland, Oregon, 97205

Other trials in United States

About this study

The AIMS study compares a methamphetamine-specific treatment intervention to a treatment-as-usual Functional Family Therapy (FFT) approach for adolescents ages 15 to 19. Adolescents are assigned to one of two treatment conditions: (1) 16 weeks of FFT designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use; or (2) 16 weeks of a combination of FFT and a methamphetamine-specific intervention involving group and individual therapy sessions; Families are assessed using questionnaires and interviews, and adolescents participate in neuropsychological testing, before, during, and after treatment to provide information about family functioning, the adolescent's drug use, the adolescent's peers, and other factors that may contribute to treatment success. Adolescents also provide urine specimens for drug screening at assessment visits. Through a partnership with Oregon Health and Science University (OHSU), adolescents will participate in functional magnetic resonance imaging appointments at the hospital to examine regional brain blood flow during tasks designed to measure impulsivity and risk-taking behaviors. As a treatment development grant, study investigators will study adolescents' acceptance of and response to the newly developed methamphetamine-specific treatment approach.

Conditions: Behavior and Mental Disorders, Methamphetamine Disorders
Being tested: Adolescent Methamphetamine Treament (AMT), Functional Family Therapy (FFT)
Keywords: methamphetamine abuse
Medical subject headings: Behavior, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adolescent Methamphetamine Treament (AMT)Behavioural
AMT Group Therapy plus Functional Family Therapy (FFT)
Functional Family Therapy (FFT)Behavioural
FFT

Study groups in NCT00680511
Study group	Role	What they receive
1	Active comparator	Family therapy combined with methamphetamine-specific group treatment. Receives: Behavioral: Adolescent Methamphetamine Treament (AMT)
2	Active comparator	Family Therapy. Receives: Behavioral: Functional Family Therapy (FFT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Substance Use
Measured: 6 months

Secondary outcomes (1)

Engagement and retention of adolescent methamphetamine users.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Dec 2013

First posted20 May 2008 (estimated)
Study startSep 2007
Primary completionSep 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Behavior and 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00680511
Sponsor's protocol ID: DA021695
Acronym: AIMS
Status last verified: Aug 2014
First submitted: 16 May 2008
Last updated: 5 Aug 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of a Family-Based Treatment for Adolescent Methamphetamine Use
ClinicalTrials.gov ID: NCT00680511
Acronym / sponsor ID: AIMS / DA021695
Conditions: Behavior and Mental Disorders, Methamphetamine Disorders
Keywords: methamphetamine abuse
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Oregon Research InstituteUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Sep 2007
Primary completion: Sep 2013 (actual)
Study completion: Dec 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Behavioral: Adolescent Methamphetamine Treament (AMT)Family therapy combined with methamphetamine-specific group treatment.
2	Active comparator	Behavioral: Functional Family Therapy (FFT)Family Therapy.

Who may qualify

Ages: 15 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

15 to 19 years of age.
Have at least one parent or parent figure willing to participate.
Meet DSM-IV diagnostic criteria for drug-abuse or dependence, including a specific meth use disorder.
Reports meth use on at least 5 of the previous 90 days.
Have contact with the parent on at least 40% of the past 90 days.

Key exclusion criteria (3 listed)

Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures.
Have a medical or psychological condition that would preclude undergoing the fMRI scan.
Have a sibling who is participating in the study.

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
Adolescent Methamphetamine Treament (AMT)AMT Group Therapy plus Functional Family Therapy (FFT)	Behavioural	1
Functional Family Therapy (FFT)FFT	Behavioural	2

Primary outcome

Substance Use
Time frame: 6 months

1 secondary outcome

Engagement and retention of adolescent methamphetamine users.
Time frame: 6 months

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 5 Aug 2014.

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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.

Holly B. Waldron, Ph.D. principal investigator

Oregon Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 3 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 5 Aug 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?

Substance Use (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00680511.

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 5 Aug 2014.