NCT03287180

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

Adolescent Community Reinforcement Approach (A-CRA) Implementation in Combination With Buprenorphine/Naloxone for Young Adults Ages 18 to 25 With Severe Opioid Use Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-Related Disorders
• Behavior, Addictive

Interventions

Type	Name	Description
BEHAVIORAL	Adolescent Community Reinforcement Approach (A-CRA)	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.
OTHER	Combination of buprenorphine/naloxone 4/1	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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-06-09
• Completion: 2020-06-09
• First posted: 2017-09-19
• Last updated: 2020-07-28