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Opioid-Dependence Among AdolescentsPhase 2NCT00182572

Science-Based Treatment for Opioid-Dependent Adolescents

A Phase 2 study testing buprenorphine, naltrexone and behavior therapy in people with Opioid-Dependence Among Adolescents, run by National Development and Research Institutes, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Opioid-Dependence Among Adolescents
What is being tested?
buprenorphine, naltrexone and behavior therapy
Type of treatment
Surgery or procedure
How many people
80 participants
Where
1 siteUnited States
Study dates
Jul 2005to not given
Phase
Phase 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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • clinical diagnosis of opioid dependence
  • ages 13-18 years

Who cannot join

  • active psychosis
  • active suicidality
  • major medical problems (e.g., cardiovascular disease)
  • pregnancy
  • require inpatient detoxification from non-opiate drugs

Trial locations and contacts

1 site in 1 country.

Lisa Marsch, PhD contact

212-636-1253

marsch@ndri.org

Ramon Solhkhah, MD contact

212-523-3069

RSolhkha@chpnet.org

United States1 site, 1 recruiting
  • Behavioral Science Research Unit, St. Luke's Hospital

    New York, New York, 10025

    Lisa Marsch, PhD

    Recruiting

Other trials in United States

About this study

The purpose of this study is to evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.

Read the detailed description

Adolescents are increasingly abusing and becoming dependent on heroin and other opioids. The number of emergency room visits related to heroin among 12-17 year olds rose almost 600%, and the self-reported prevalence of heroin use among this group more than doubled in the last decade. As a result of the increased availability of high-potency, low-cost heroin, many adolescents initiate heroin use by snorting it; however, many often then progress to injection of heroin. Despite the critical need to identify efficacious treatments for this population, virtually no research has been conducted to systematically characterize or evaluate treatment interventions for adolescent heroin and opioid abusers. We recently conducted the first controlled study funded by NIDA to systematically evaluate the efficacy of several pharmacotherapies as detoxification agents along with intensive behavioral interventions in the treatment of this population. The purpose of this study is to evaluate ways to further improve on the promising outcomes from our initial study via combined behavioral-buprenorphine treatment for opioid-dependent youth. The primary aim is to examine if improved treatment outcomes can be achieved if the duration of buprenorphine detoxification is lengthened (when the rate of decrease in buprenorphine dose is slower, withdrawal symptoms may be of reduced intensity and youth are provided with a greater opportunity to learn new skills and behaviors addressing how they might best discontinue their opiate use, prevent relapse, and meet treatment goals). A secondary aim is to examine if the provision of monetary voucher-based incentives contingent on consumption of the opioid antagonist, naltrexone, reduces rates of relapse to opiate use in adolescents post-detoxification compared to when no such incentives are provided. This analysis may provide critical empirical information regarding how to best prevent relapse to opioid use among opioid-dependent youth. Another secondary aim is to identify significant predictors of treatment outcome. We will thus conduct an exploratory evaluation of demographic, baseline drug use, psychological and other history variables that may predict successful treatment outcomes. This work may help inform the refinement of treatment interventions for various sub-populations of opioid-dependent youth. Outcome measures will include opiate and other drug abstinence, retention, opiate withdrawal symptoms, HIV risk behavior, family relationships, as well as a variety of other secondary outcome measures. We plan to collect these measures at intake, during treatment and at several post-treatment follow-up timepoints. Overall, this research will contribute new empirical information that will inform the development of effective treatment interventions for the largely unstudied and rapidly expanding population of opioid-dependent youth.

Being tested
buprenorphine, naltrexone, behavior therapy, voucher-based contingency management
Keywords
heroin, opiate, addiction, adolescent, treatment
Medical subject headings
Behavior, Addictive

What participants receive

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

  • buprenorphineDrug

  • naltrexoneDrug

  • behavior therapyProcedure or surgery

  • voucher-based contingency managementProcedure or surgery

What is being measured

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

  1. opiate use

Secondary outcomes (9)
  1. treatment retention

  2. other drug use

  3. HIV risk behavior

  4. opiate agonist and withdrawal effects

  5. psychological status

  6. family relations

  7. motivation to change drug use

  8. opiate craving

  9. criminal activity

Timeline

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

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2005

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00182572
Sponsor's protocol ID
R01DA018297
Status last verified
Aug 2008
First submitted
10 Sep 2005
Last updated
12 Aug 2008
Results posted
No

Publications

  • Marsch LA, Moore SK, Borodovsky JT, Solhkhah R, Badger GJ, Semino S, Jarrett K, Condon KD, Rossettie K, Vincent P, Hajizadeh N, Ducat E. A randomized controlled trial of buprenorphine taper duration among opioid-dependent adolescents and young adults. Addiction. 2016 Aug;111(8):1406-15. doi: 10.1111/add.13363. Epub 2016 Apr 21.

    PubMed 26918564

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing buprenorphine, naltrexone and behavior therapy in people with Opioid-Dependence Among Adolescents, run by National Development and Research Institutes, Inc. 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 2 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: status not confirmed, as of the sponsor's last update on 12 Aug 2008. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lisa Marsch, PhD (212-636-1253, marsch@ndri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

opiate use. 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 NCT00182572, which also lists 1 linked publication.

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 12 Aug 2008.

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