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

Study 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.

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

Conditions
-----------------
Opioid-Related Disorders, Behavior, Addictive

Intervention / Treatment
-----------------
* Behavioral: Adolescent Community Reinforcement Approach (A-CRA)
* Other: Combination of buprenorphine/naloxone 4/1


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This 12-week randomized controlled pilot trial will begin by an induction on sublingual buprenorphine/naloxone for all participants who would usually receive buprenorphine based treatment in the clinic. After the two-week induction phase, participants will be randomized into two groups. While continuing buprenorphine/naloxone the experimental group will receive a 12-week course of A-CRA, while the control group will be provided medical management by the prescriber. Medical management is the standard treatment approach for prescribing buprenorphine and covers medication adherence, side effects of the medication, assessment of withdrawal/cravings and dose adjustment as indicated. After completion of the 12-week A-CRA intervention, all individuals will receive weekly medical management sessions until week 24 (6 month follow up).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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). | Behavioral: Adolescent Community Reinforcement Approach (A-CRA)<br>* 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.<br>Other: Combination of buprenorphine/naloxone 4/1<br>* 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.<br>* Other names: Suboxone/Narcan;|
| Active Comparator: Control group<br>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). | Other: Combination of buprenorphine/naloxone 4/1<br>* 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.<br>* Other names: Suboxone/Narcan;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Pre-treatment (baseline) and post-study intervention (12 weeks visit after completion of A-CRA ), and end of follow-up (24-week visit) . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24-week visit | 
| Number of clinic visits by patient and any expected joint family member sessions | To investigate any difference in treatment retention in the experimental group compared to the control group. | 2-, 12, and 24-week visits. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacotherapy, Randomized controlled, Adolescent Community Reinforcement Approach, A-CRA, Opioid-Related Disorders, Behavior, Psychosocial treatment, Adolescent, Young adult