Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents

Context: Standard treatment of opioid dependence in adolescents is detoxification and
counseling, which results in relapse in 20-50% of patients. Alternative medical treatments
include buprenorphine and naltrexone that have not been well investigated in adolescents and
young adults. Buprenorphine has previously been shown effective in the treatment of opioid
dependence in adolescents in one study in the United States as compared to detoxification.
Although naltrexone treatment results in low compliance in adults, it is effective in
combination with a strong social support network that exists in adolescents that live with
at least 1 parent/guardian.

Objective: To compare the efficacy of buprenorphine/naloxone pharmacotherapy with
naltrexone pharmacotherapy on treatment retention, relapse prevention and craving reduction
among opioid-addicted adolescents and young adults.

Design: 2-arm Randomized Comparative Effectiveness Pharmacotherapy Clinical Trial.

Setting: The study will be conducted in an outpatient treatment facility Participants: The
participants will be those who 1) are between 16-25 years old, 2) have clear evidence of a
substance use disorder with opioid dependence, and 3) live with at least one parent.

Baseline data collection: Data collected at baseline will include (with examples),
demographics (age, gender, race), substance use history (type of substances used, duration
of use, routes of abuse), co-existing medical problems (seizures, hepatitis C), prior mental
health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient,
inpatient), socioeconomic variables (educational level, occupation, employment history),
criminal history (number of arrests and convictions, total amount of time spent in jail or
prison), family history (first degree relatives with substance use disorders) and scores on
psychometric testing (DAST, opioid craving score).

Outcome data: Four main outcomes will be examined: Retention in treatment, self-reported
opioid craving, self-reported drug use with urine toxicology confirmation. Retention in
treatment (1-180 days) will be measured by the date that participant was last seen by study
personnel or date when participant completes study following the date of enrollment. Opioid
carving (1-10) will be measured by a 10 point visual analog scale. Self-reported drug use
(days to first use and percent days abstinent) will be measured by time line follow back.
Urine toxicology (yes/no) will be determined at baseline and monthly at 1, 2, 3, 4, 5, 6
months follow-up.

Data analysis: Outcome variables will be compared between the two groups using t-tests or
chi-square tests as appropriate. A Kaplan-Myer survival analysis will be used to describe
participant participation. Predictors of poor outcomes will be identified using a
case-control design in which those with poor outcomes (the "cases") will be compared to
those with successful outcomes (the "controls") using multivariate techniques (logistic
regression).

Inclusion Criteria:

- Clinical Diagnosis of Opiate Dependence

- Successful completion of detoxification

- can answer 9 out of 10 question correctly that tests understanding of the study

Exclusion Criteria:

- unable to pay for medication

- not living with a parent/guardian

- inability of patient and/or parent to give consent

- major co-occurring psychiatric disorder

- existing medical condition that would interfere with the treatment

- use of CNS depressants

- pregnancy