Adolescent Community Reinforcement Approach (A-CRA) Implementation in Combination With Buprenorphine/Naloxone for Young Adults Ages 18 to 25 With Severe Opioid Use Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Opioid-Related Disorders
- Sponsor
- Emory University
- Primary Endpoint
- Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
Justine Welsh
Assistant Professor
Emory University
Eligibility Criteria
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
Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs
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) .
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
Time Frame: 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 Outcomes
- Completion of the final phase of treatment defined as final study session (yes/no)(24-week visit)
- Number of clinic visits by patient and any expected joint family member sessions(2-, 12, and 24-week visits.)