Clinical trial NCT01690546: Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence
Official title: An Open Label, Flexible Dose Study of Very Low Doses of Naltrexone-Buprenorphine Transfer to Extend-Release Naltrexone (VIVITROL®) in Opioid Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Dependence
Keywords: Opioid Addiction
Addiction
Drug Dependence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
First posted: 2012-09-21
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention in Treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)
timeFrame: 4 weeks
measure: Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)
timeFrame: 4 weeks
measure: Craving
timeFrame: 4 weeks
measure: Illicit Drug Use, Measured by Urine Drug Testing
timeFrame: 4 weeks
measure: Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire
timeFrame: Day 9
measure: Percentage of Participants Who Adhered to Study Visits.
timeFrame: baseline to end of study (approximately 40 days)
measure: Percentage of Participants With Adherence to Medication (Naltrexone)
timeFrame: Day 1 to Day 8 (+/- 2 days)
measure: Use of Ancillary Medications.
timeFrame: baseline to week 1
measure: Number of Participants That Self Reported Illicit Drug Use
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center / Civitan Building
state: North Carolina
Study officials:
affiliation: Duke University Health Systems
name: Paolo Mannelli, MD
role: PRINCIPAL_INVESTIGATOR
References: