Clinical trial NCT03287180: Adolescent Community Reinforcement Approach in Combination With Buprenorphine/Naloxone for Severe Opioid Use
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid-Related Disorders
Behavior, Addictive
Keywords: Adolescent Community Reinforcement Approach
A-CRA
Opioid-Related Disorders
Behavior
Psychosocial treatment
Pharmacotherapy
Randomized controlled
Adolescent
Young adult
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Chestnut Health Systems
First posted: 2017-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage
timeFrame: Each session (weekly) up to 24 weeks.
measure: Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs
timeFrame: Pre-treatment (baseline) and post-study intervention (12 weeks visit after completion of A-CRA ), and end of follow-up (24-week visit) .
Secondary outcomes:
measure: Completion of the final phase of treatment defined as final study session (yes/no)
timeFrame: 24-week visit
measure: Number of clinic visits by patient and any expected joint family member sessions
timeFrame: 2-, 12, and 24-week visits.
Other outcomes:
Locations:
Study officials:
affiliation: SOM: Psych: Child Psych - CAMP Emory University
name: Justine Welsh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.
citation: Jones CM, Logan J, Gladden RM, Bohm MK. Vital Signs: Demographic and Substance Use Trends Among Heroin Users - United States, 2002-2013. MMWR Morb Mortal Wkly Rep. 2015 Jul 10;64(26):719-25.
citation: Godley SH, Smith JE, Passetti LL, Subramaniam G. The Adolescent Community Reinforcement Approach (A-CRA) as a model paradigm for the management of adolescents with substance use disorders and co-occurring psychiatric disorders. Subst Abus. 2014;35(4):352-63. doi: 10.1080/08897077.2014.936993.
citation: Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003 Apr-Jun;35(2):253-9. doi: 10.1080/02791072.2003.10400007.
citation: Rudd RA, Aleshire N, Zibbell JE, Gladden RM. Increases in Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR Morb Mortal Wkly Rep. 2016 Jan 1;64(50-51):1378-82. doi: 10.15585/mmwr.mm6450a3.