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.
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.
United States1 site, 1 recruiting
- Recruiting
Behavioral Science Research Unit, St. Luke's Hospital
New York, New York, 10025
Lisa Marsch, PhD
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.
- Conditions
- Opioid-Dependence Among Adolescents
- 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.
opiate use
Secondary outcomes (9)
treatment retention
other drug use
HIV risk behavior
opiate agonist and withdrawal effects
psychological status
family relations
motivation to change drug use
opiate craving
criminal activity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-Dependence Among AdolescentsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Development and Research Institutes, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Investigators
- Lisa Marsch, PhD, Principal investigator, National Development and Research Institutes, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Science-Based Treatment for Opioid-Dependent Adolescents
- ClinicalTrials.gov ID
- NCT00182572
- Acronym / sponsor ID
- R01DA018297
- Conditions
- Opioid-Dependence Among Adolescents
- Keywords
- heroin, opiate, addiction, adolescent, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Development and Research Institutes, Inc.University, hospital or other
- Collaborators
- St. Luke's-Roosevelt Hospital Center
- Study start
- Jul 2005
- First posted
- 16 Sep 2005 (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 evaluate ways to optimize outcomes from combined behavioral-pharmacological treatment for opioid-dependent youth.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of opioid dependence
- ages 13-18 years
Key exclusion criteria (5 listed)
- active psychosis
- active suicidality
- major medical problems (e.g., cardiovascular disease)
- pregnancy
- require inpatient detoxification from non-opiate drugs
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 |
|---|---|---|
| buprenorphine | Drug | – |
| naltrexone | Drug | – |
| behavior therapy | Procedure or surgery | – |
| voucher-based contingency management | Procedure or surgery | – |
Primary outcome
opiate use
9 secondary outcomes
treatment retention
other drug use
HIV risk behavior
opiate agonist and withdrawal effects
psychological status
family relations
motivation to change drug use
opiate craving
criminal activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2008.
- Derived from this study: PubMed 26918564Marsch 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.
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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.
Lisa Marsch, PhD principal investigator
National Development and Research Institutes, Inc.
1 site in 1 country: see every site and its status.
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.