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

Paolo Mannelli

Status and phase: Completed; Phase 2

Conditions: Opiate Dependence

Treatments: Drug: buprenorphine/naloxone; Drug: extended release naltrexone; Drug: very low dose naltrexone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01690546

Pro00036909

Details and patient eligibility

About

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.

Full 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 1-3, participants will receive buprenorphine/naloxone daily at a starting dose of 4mg, progressively decreasing to 2 mg on days 2- 3. Participants will also receive very low dose naltrexone (VLNTX) at a dose of 0.25 mg to 1mg on Days 1-3, 2 to 6 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

BUP/VLNXT to VIVITROL

Experimental group

Description:

On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 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.

Treatment:

Drug: very low dose naltrexone

Drug: extended release naltrexone

Drug: buprenorphine/naloxone