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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Duke University
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Paolo Mannelli, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01690546
First received: September 19, 2012
Last updated: October 23, 2014
Last verified: October 2014

September 19, 2012
October 23, 2014
September 2012
February 2015   (final data collection date for primary outcome measure)
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.
Treatment Completion [ Time Frame: 37 days ] [ Designated as safety issue: No ]
Subjects are required to complete the 9 days of titration for opioid withdrawal. Then the 4 week follow-up period after the Vivitrol injection.
Complete list of historical versions of study NCT01690546 on ClinicalTrials.gov Archive Site
  • 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).

Withdrawal Intensity [ Time Frame: 37 days ] [ Designated as safety issue: No ]

Withdrawal symptoms will be assesssed with the following scales:

  • Subjective Opioid Withdrawal Scale (SOWS)
  • Clinical Opioid Withdrawal Scale (COWS)
  • Craving, assessed with a 20-point Visual Analog Scale (VAS)
Not Provided
Not Provided
 
Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
  • 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
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.
Interventions:
  • Drug: very low dose naltrexone
  • Drug: extended release naltrexone
  • Drug: buprenorphine/naloxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2015
February 2015   (final data collection date for primary outcome measure)

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.

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.
Both
18 Years to 65 Years
No
Contact: Josephine E White-Harper, BA 919-681-0613 josephine.white@duke.edu
United States
 
NCT01690546
Pro00036909
Yes
Paolo Mannelli, Duke University Medical Center
Paolo Mannelli
Alkermes, Inc.
Principal Investigator: Paolo Mannelli, MD Duke University Health Systems
Duke University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP