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Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence (BUP/NXT-VIVI)

This study is currently recruiting participants.
Verified May 2013 by Duke University
Sponsor:
Collaborator:
Alkermes
Information provided by (Responsible Party):
Paolo Mannelli, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01690546
First received: September 19, 2012
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate a very low dose naltrexone-buprenorphine treatment to transfer opioid dependent individuals to extended release naltrexone injection (Vivitrol). The hypothesis is that patients will complete the transfer to Vivitrol successfully, finding the treatment acceptable and showing minimal withdrawal discomfort.


Condition Intervention Phase
Opiate Dependence
 Drug: very low dose naltrexone
Drug: extended release naltrexone
Drug: buprenorphine/naloxone
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Retention in Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.


Secondary Outcome Measures:
  • Withdrawal Intensity (COWS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.

    COWS = Clinical Opiate Withdrawal Scale. COWS rates eleven common opiate withdrawal signs or symptoms. The summed scores are used in the assessment 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal


  • Withdrawal Intensity (SOWS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    After the initial titration period for opioid withdrawal (of up to 8 days), patients will receive the Vivitrol injection. Then, we will follow patients for retention out to 4 weeks and record the total time they remained in treatment.

    SOWS = Subjective Opiate Withdrawal Scale. SOWS contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).



Estimated Enrollment: 20
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BUP/VLNXT to VIVITROL
On days 1-4, participants will receive buprenorphine/naloxone daily at a starting dose of between 4 to 8 mg, progressively decreasing to 2 mg on by day 4. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg on Days 1-3, 2.5 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL (extended release naltrexone) injection, 380 mg, will be administered on Day 8.
 Drug: very low dose naltrexone
On days 1-4, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 to 8 mg, progressively decreasing to 2 mg on Days 1-4 and very low dose naltrexone at 0.25 mg on Days 1-3, 2.5 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Drug: extended release naltrexone
On days 1-4, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 to 8 mg, progressively decreasing to 2 mg on Days 1-4 and very low dose naltrexone at 0.25 mg on Days 1-3, 2.5 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Other Name: Vivitrol
Drug: buprenorphine/naloxone
On days 1-4, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 to 8 mg, progressively decreasing to 2 mg on Days 1-4 and very low dose naltrexone at 0.25 mg on Days 1-3, 2.5 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
Other Name: Suboxone

Detailed Description:

Twenty opioid dependent (OD) volunteers seeking treatment will be enrolled in an open-label, flexible-dosing, outpatient trial at Duke Addictions Program. On days 1-4, participants will receive buprenorphine/naloxone daily at a starting dose of between 4 to 8 mg, progressively decreasing to 2 mg on by day 4. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg on Days 1-3, 2.5 mg on Day 4 and between 10 and 50 mg on Days 5-7. Then a VIVITROL injection, 380 mg, will be administered on Day 8.

Evaluations will occur daily for up to 6 hours until 1 day after VIVITROL injection and then weekly for 4 weeks. Patients will receive ancillary medications as needed and weekly psychosocial intervention. At the end of the study, participants will be offered outpatient treatment of OD at the study site, or will be referred to other treatment programs.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women 18 to 65 years of age who meet DSM-IV criteria for OD of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
  2. Individuals must be capable of giving informed consent and capable of complying with study procedures.

  3. Participants will be asked to provide locator information including the address and telephone number of a non-drug abusing relative or friend who can reach the participant in emergencies.

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Exclusion Criteria:

  1. Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
  2. Individuals regularly using licit or illicit methadone or BUP.
  3. Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
  4. Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
  5. Individuals with current suicidal risk or 1 or more suicide attempts within the past year.
  6. History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification, defined as an episode of opioid-induced unconsciousness or incapacitation.
  7. Nursing/pregnant women, or failure in a sexually active man or woman to use adequate contraceptive methods (e.g., oral or depot contraceptives, foam, sponges, and/or condoms)
  8. Individuals who are dependent on any other drugs (excluding nicotine)
  9. Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.
  10. Individuals who are court-mandated to treatment.

  11. Individuals who have a current or pending legal status, or any other condition that would make them unlikely to be available for the duration of the study.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690546

Contacts
Contact: Josephine E White-Harper, BA 919-681-0613 josephine.white@duke.edu

Locations
United States, North Carolina
Duke University Medical Center / Civitan Building Recruiting
Durham, North Carolina, United States, 27713
Contact: Josephine E White-Harper, BA     919-681-0613     josephine.white@duke.edu    
Principal Investigator: Paolo Mannelli, MD            
Sponsors and Collaborators
Paolo Mannelli
Alkermes
Investigators
Principal Investigator: Paolo Mannelli, MD Duke University Health Systems
  More Information

No publications provided

Responsible Party: Paolo Mannelli, Associate Professor of Psychiatry, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01690546     History of Changes
Other Study ID Numbers: Pro00036909
Study First Received: September 19, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Opioid Addiction
Addiction
Drug Dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Naltrexone
Naloxone
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 22, 2013