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

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.

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.