Clinical trial NCT00182572: Science-Based Treatment for Opioid-Dependent Adolescents
Official title: Science-Based Treatment for Opioid-Dependent Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Opioid-Dependence Among Adolescents
Keywords: heroin
opiate
addiction
adolescent
treatment
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: St. Luke's-Roosevelt Hospital Center
First posted: 2005-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: opiate use
Secondary outcomes:
measure: treatment retention
measure: other drug use
measure: HIV risk behavior
measure: opiate agonist and withdrawal effects
measure: psychological status
measure: family relations
measure: motivation to change drug use
measure: opiate craving
measure: criminal activity
Other outcomes:
Locations:
city: New York
country: United States
facility: Behavioral Science Research Unit, St. Luke's Hospital
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Lisa Marsch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.