Adolescent Community Reinforcement Approach in Combination With Buprenorphine/Naloxone for Severe Opioid Use (A-CRA/MAT)

Emory University

Status: Withdrawn

Conditions: Opioid-Related Disorders; Behavior, Addictive

Treatments: Other: Combination of buprenorphine/naloxone 4/1; Behavioral: Adolescent Community Reinforcement Approach (A-CRA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03287180

IRB00093907

1R21DA046738-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental group

Experimental group

Description:

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).

Treatment:

Behavioral: Adolescent Community Reinforcement Approach (A-CRA)

Other: Combination of buprenorphine/naloxone 4/1

Control group

Active Comparator group

Description:

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).

Treatment:

Other: Combination of buprenorphine/naloxone 4/1