Adolescent Community Reinforcement Approach in Combination With Buprenorphine/Naloxone for Severe Opioid Use

Emory University

Overview

The study assesses whether adding a behavioral intervention, known as the Adolescent Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving buprenorphine/naloxone can improve treatment success and retention rates in young adults with severe opioid use disorder.

Buprenorphine is one of the medication assisted treatments approved by the FDA for opioid use disorders. Treatment with buprenorphine/naloxone may reduce the risk of opioid overdose and lower the occurrence of further conditions associated with injection drug use such as psychiatric disorders, hepatitis C infection, HIV, and high-risk sexual and criminal behaviors. The study assesses whether adding a behavioral intervention, known as the Adolescent Community Reinforcement Approach (A-CRA), to the treatment of individuals already receiving buprenorphine/naloxone can improve treatment success and retention rates in young adults with severe opioid use disorder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Interventions

Adolescent Community Reinforcement Approach (A-CRA)BEHAVIORAL

The A-CRA is a modified version of the Community Reinforcement Approach for adolescents and transitional age youth. The A-CRA treatment protocol consists of nineteen procedures designed to promote positive behavior change directed towards prosocial activities and engagement in the individual's community. A community can include but is not limited to: social and peer activities, family interaction, and work or school environments. Some of the highlighted procedures include relapse prevention, sobriety sampling, problem solving, and communication skills. There are also combined parent/and or couples relationship sessions with the young adult. In the current study, 12-weeks of A-CRA treatment will be provided to the intervention group.

Combination of buprenorphine/naloxone 4/1OTHER

Buprenorphine is a partial agonist at mu-opioid receptor, an antagonist at kappa-opioid receptor. Naloxone is an antagonist at the mu-opioid receptor. Buprenorphine/naloxone requires the use of an induction to avoid the risk of withdrawal. Participants are instructed not to use opioids for at least 10 hours prior to first dose. Once symptoms of withdrawal score a minimum of 7 on the Clinical Opiate Withdrawal Scale (COWS), the first dose of 4/1 mg will be given. Participants will be monitored for an hour. An additional 4/1 mg dose can be provided to a dose that suppresses withdrawal effects. The physician then provides a prescription for 8/2-16/4 mg for Day 2. Doses can be adjusted with a maximum of total 24/6 mg/day. The target daily dose is 16/4 mg.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: * have met DSM-5 criteria for severe opioid use disorder * no sensitivity to buprenorphine or naloxone * no further medical/addictive conditions that require immediate medical attention * ability to read and provide informed consent * intent to remain in the area for the duration of the study * able to receive outpatient care * agreed to use an acceptable birth control method throughout the duration of this study (female participants) Exclusion Criteria: * endorsement of imminent and serious suicidality * medical conditions that take precedence over the presence of treatment for an addictive disorder * history of an adverse reaction to buprenorphine/naloxone * current substance use or psychiatric condition requiring a level of care higher than outpatient * pregnant, nursing or planning pregnancy during the extent of the treatment trial(female participants)

Outcomes

Primary Outcomes

Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage

Qualitative urine test for opiates (+/-) will be performed. All presumptive positive assays will be confirmed by Gas Chromatography-Mass Spectrometry. The concentration value must be greater than or equal to the cutoff to be reported as positive. The opiates test results (positive/negative) will be documented. Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage will be reported.

Time frame: Each session (weekly) up to 24 weeks.

Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs

The Global Appraisal of Individual Needs is a comprehensive, semi-structured interview measure with established validity and reliability used to identify and address a wide range of psychosocial problems in clinical populations. Average administration time for the GAIN Intake version is 1.5 hours and 45 minutes for the follow-up version. The assessment categories include background, school problems, work problems, physical health, sources of stress, risk behaviors and infectious diseases, mental health, substance use, and crime and violence. Substance use categories document self-reported frequency of substance use within the past 90 days for each substance endorsed (alcohol, opioids, marijuana, and other illicit psychoactive drugs). Individuals are able to say that they do not know, or refuse to answer any questions that they do not want to answer.

Time frame: Pre-treatment (baseline) and post-study intervention (12 weeks visit after completion of A-CRA ), and end of follow-up (24-week visit) .

Secondary Outcomes

Completion of the final phase of treatment defined as final study session (yes/no)

To investigate any difference in treatment retention in the experimental group compared to the control group.

Time frame: 24-week visit

Number of clinic visits by patient and any expected joint family member sessions

Data from ClinicalTrials.gov

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