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

Completed · Phase 2

Conditions studied: Opiate Dependence

In brief

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.

Key facts

Study ID

NCT01690546

Run by

Paolo Mannelli

People needed

38

Starts

2012-09-01

Expected to finish

2015-02-01

Last updated by the study team

2016-06-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Individuals must be capable of giving informed consent and capable of complying with study procedures.
• 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.

You may not qualify if…

• Individuals currently prescribed or regularly taking opiates for chronic pain or medical illness.
• Individuals regularly using licit or illicit methadone or BUP.
• Individuals meeting DSM-IV criteria for schizophrenia, schizoaffective or psychotic disorders, or psychiatric disorder (other than substance abuse) requiring intervention.
• Individuals who are medically unstable, or have liver enzyme function tests greater than two times normal.
• Individuals with current suicidal risk or 1 or more suicide attempts within the past year.
• 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.
• 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)
• Individuals who are dependent on any other drugs (excluding nicotine)
• Individuals with known sensitivity to BUP, VIVITROL, NTX, naloxone.
• Individuals who are court-mandated to treatment.
• 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.

Where it is running

• Duke University Medical Center / Civitan Building — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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