Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

Opiate Dependence Clinical Trial

— BUP/NXT-VIVI  

Official title:

An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690546
• Other study ID #: Pro00036909
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2012
• Last updated: June 8, 2015
• Start date: September 2012
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Thirty-five 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center / Civitan Building	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Paolo Mannelli	Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in Treatment	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.	4 weeks	No
Secondary	Withdrawal Intensity (COWS)	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	4 weeks	No
Secondary	Withdrawal Intensity (SOWS)	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).	4 weeks	No