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Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

Information source: New York University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opioid Use Disorder

Intervention: Extended-Release Naltrexone (Drug); Buprenorphine-Naloxone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: New York University School of Medicine

Official(s) and/or principal investigator(s):
John Rotrosen, MD, Principal Investigator, Affiliation: New York University School of Medicine

Overall contact:
Sarah Farkas, MA, Email: sarah.farkas@nyumc.org

Summary

CTN-0051 will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol«), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone«), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery. The study will be conducted in approximately 8 NIDA Clinical Trials Network affiliated community based treatment programs. Approximately 400 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks. The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i. e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i. e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.

Clinical Details

Official title: CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to relapse

Secondary outcome:

Proportion successfully inducted onto assigned study medication (binary: did or did not receive first dose of XR-NTX, or achieve maintenance dose of BUP-NX)

Adverse Events related to study medications

Opioid abstinence over time while on study medication (Weekly TLFB, confirmed by urine drug screens)

Alcohol and other drug use, over time (TLFB and UDS)

Cigarette smoking (FTND, Tobacco Use Questionnaire, VAS nicotine craving)

Opioid Craving (VAS) over time

Subacute withdrawal symptoms over time (HAM-D, SOWS)

Problems related to drug abuse (ASI-Lite and EQ-5D)

HIV risk behavior over time (RAB and other HIV risk measures)

Cognitive function (Trails Making Test Parts A and B, Stroop)

Economic costs

Quality-adjusted life year (QALY) outcomes

Cost-effectiveness and cost-benefit

Detailed description: For opioid-dependent patients in the U. S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment. Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications. The overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact. To this end CTN-0051 will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery. The study will be conducted in approximately 8 CTN-affiliated CTPs that provide detoxification services (inpatient/residential), have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period. Approximately 400 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks. To maximize generalizability, the point of randomization will be flexible, from shortly after program admission until just prior to program discharge. A study design modification (a shift to a later point of randomization) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i. e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction). The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i. e.., loss of persistent abstinence) during the 6-month trial. The primary outcome measure will be the time to the event, with the event called relapse. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i. e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments. Toward the end of the 24-week treatment period, participants will be referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes will be assessed at week 28 and week 36 after randomization. For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study will provide a two-week BUP-NX taper (beginning at the week 24 visit). In an ancillary genetics study we plan to study functional variants in three genes (OPRM1, OPRK1 and PDYN), known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated in CTN-0051 for their contribution to treatment retention, abstinence, and depression. Blood collection for DNA extraction will occur at the same time that blood is collected for medical safety and liver function evaluation, precluding the need for an additional needle-stick. Coded blood samples for the genetics studies will be sent to the NIDA Center for Genetics Repository.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Male or female

- 18 years of age and older

- Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)

- Have used opioids other than as specifically prescribed within thirty days prior to

consent

- Seeking treatment for opioid dependence and willing to accept "agonist-based" or

"antagonist-based" therapy

- In good-enough general health, as determined by the study physician on the basis of

medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX

- Able to provide written informed consent

- Able to speak English sufficiently to understand the study procedures and provide

written informed consent to participate in the study

- If female of childbearing potential, be willing to practice an effective method of

birth control for the duration of participation in the study Exclusion Criteria

- Serious medical, psychiatric or substance use disorder that, in the opinion of the

study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include: 1. Disabling or terminal medical illness (e. g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments; 2. Severe, untreated or inadequately treated mental disorder (e. g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview; 3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)

- LFTs (ALT, AST) greater than 5 times upper limit of normal

- Suicidal or homicidal ideation that requires immediate attention

- Known allergy or sensitivity to buprenorphine, naloxone, naltrexone,

polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent

- Maintenance on methadone at doses of 30mg or greater at the time of signing consent

- Presence of pain of sufficient severity as to require ongoing pain management with

opioids

- Pending legal action or other reasons that might prevent an individual from

completing the study

- If female, currently pregnant or breastfeeding, or planning on conception

- Body habitus that, in the judgment of the study physician, precludes safe

intramuscular injection of XR-NTX (e. g., BMI>40, excess fat tissue over the buttocks, emaciation)

Locations and Contacts

Sarah Farkas, MA, Email: sarah.farkas@nyumc.org

Tarzana Treatment Centers, Tarzana, California 91356, United States; Recruiting
Leonardo Colemon, Phone: 818-996-1051, Ext: 1105, Email: lcolemon@tarzanatc.org

Gateway Community Services, Inc., Jacksonville, Florida 32201, United States; Recruiting
Sarah Kim, Phone: 904-387-4661, Ext: 1073, Email: skim@gatewaycommunity.com

Avery Road Treatment Center, Rockville, Maryland 20853, United States; Recruiting
Laura Augustine, Phone: 410-233-1400, Ext: 247, Email: laugustine@mountainmanor.org

Stanley Street Treatment and Resources, Fall River, Massachusetts 02720, United States; Recruiting
Michelle Rapoza, Email: research@sstar.org

Turquoise Lodge Hospital, Albuquerque, New Mexico 87108, United States; Recruiting
Christine Lizarraga, Phone: 505-681-6930

Bellevue Hospital Center, New York, New York 10016, United States; Recruiting
Sarah Meyers-Ohki, Phone: 646-501-4123, Email: sarah.meyers-ohki@nyumc.org

Maryhaven, Columbus, Ohio 43207, United States; Recruiting
Monique Lumpkin, Phone: 614-324-5430, Email: mlumpkin@maryhaven.com

Evergreen Treatment Services, Seattle, Washington 98134, United States; Active, not recruiting

Additional Information

Starting date: January 2014
Last updated: April 28, 2015

Page last updated: August 23, 2015

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