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

Not Applicable

Withdrawn

• Conditions: Opioid-Related Disorders; Behavior, Addictive
• Interventions: Other: Combination of buprenorphine/naloxone 4/1; Behavioral: Adolescent Community Reinforcement Approach (A-CRA)

• Registration Number: NCT03287180
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Study Start: 2019-01-01
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Combination of buprenorphine/naloxone 4/1	Participants in the control condition will attend weekly individual medical management sessions with the MD who will also provide a prescription for a combination of buprenorphine/naloxone 4/1 (approximately 25 minutes in duration).
Experimental group	Adolescent Community Reinforcement Approach (A-CRA)	Participants in the experimental group will attend one individual assessment with the study physician for combination of buprenorphine/naloxone 4/1 prescription and urinalysis, along with one weekly Adolescent Community Reinforcement Approach (A-CRA) session (approximately 50 minutes).
Experimental group	Combination of buprenorphine/naloxone 4/1	Participants in the experimental group will attend one individual assessment with the study physician for combination of buprenorphine/naloxone 4/1 prescription and urinalysis, along with one weekly Adolescent Community Reinforcement Approach (A-CRA) session (approximately 50 minutes).

Primary Outcome Measures

Name	Time	Method
Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs	Pre-treatment (baseline) and post-study intervention (12 weeks visit after completion of A-CRA ), and end of follow-up (24-week visit) .	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.
Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage	Each session (weekly) up to 24 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Completion of the final phase of treatment defined as final study session (yes/no)	24-week visit	To investigate any difference in treatment retention in the experimental group compared to the control group.
Number of clinic visits by patient and any expected joint family member sessions	2-, 12, and 24-week visits.	To investigate any difference in treatment retention in the experimental group compared to the control group.