Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA046738-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
unable to enroll any participants
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Chestnut Health Systems | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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). |
|
| Control group | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adolescent Community Reinforcement Approach (A-CRA) | Behavioral | 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. |
| 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) . |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Justine Welsh, MD | SOM: Psych: Child Psych - CAMP Emory University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10842426 | Background | Arnett JJ. Emerging adulthood. A theory of development from the late teens through the twenties. Am Psychol. 2000 May;55(5):469-80. | |
| 26158353 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
|
| Combination of buprenorphine/naloxone 4/1 | Other | 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. |
|
|
To investigate any difference in treatment retention in the experimental group compared to the control group. |
| 2-, 12, and 24-week visits. |
| 25035906 | Background | 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. |
| 12924748 | Background | 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. |
| 26720857 | Background | 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. |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided