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

Primary Purpose

Opioid-Related Disorders, Behavior, Addictive

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Adolescent Community Reinforcement Approach (A-CRA)

Combination of buprenorphine/naloxone 4/1

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Adolescent Community Reinforcement Approach, A-CRA, Opioid-Related Disorders, Behavior, Psychosocial treatment, Pharmacotherapy, Randomized controlled, Adolescent, Young adult

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03287180

First Posted

September 7, 2017

Last Updated

July 24, 2020

Sponsor

Emory University

Collaborators

National Institute on Drug Abuse (NIDA), Chestnut Health Systems

1. Study Identification

Unique Protocol Identification Number

NCT03287180

Brief Title

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

Acronym

A-CRA/MAT

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Withdrawn

Why Stopped

unable to enroll any participants

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

June 9, 2020 (Actual)

Study Completion Date

June 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Institute on Drug Abuse (NIDA), Chestnut Health Systems

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders, Behavior, Addictive

Keywords

Adolescent Community Reinforcement Approach, A-CRA, Opioid-Related Disorders, Behavior, Psychosocial treatment, Pharmacotherapy, Randomized controlled, Adolescent, Young adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Adolescent Community Reinforcement Approach (A-CRA)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Combination of buprenorphine/naloxone 4/1

Other Intervention Name(s)

Suboxone/Narcan

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of opiates-negative urine drug screens over the total number of urine drug screens at each stage

Description

Time Frame

Each session (weekly) up to 24 weeks.

Title

Percent of days of opioid use within the past 90 days as indicated by self-report on the Global Appraisal of Individual Needs

Description

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) .

Secondary Outcome Measure Information:

Title

Completion of the final phase of treatment defined as final study session (yes/no)

Description

To investigate any difference in treatment retention in the experimental group compared to the control group.

Time Frame

24-week visit

Title

Number of clinic visits by patient and any expected joint family member sessions

Description

To investigate any difference in treatment retention in the experimental group compared to the control group.

Time Frame

2-, 12, and 24-week visits.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Justine Welsh, MD

Organizational Affiliation

SOM: Psych: Child Psych - CAMP Emory University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

10842426

Citation

Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80.

Results Reference

background

PubMed Identifier

26158353

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.

Results Reference

background

PubMed Identifier

25035906

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.

Results Reference

background

PubMed Identifier

12924748

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.

Results Reference

background

PubMed Identifier

26720857

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.

Results Reference

background

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

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