NCT01690546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 1, 2016

Completed
Last Updated

June 1, 2016

Status Verified

April 1, 2016

Enrollment Period

2.4 years

First QC Date

September 19, 2012

Results QC Date

February 22, 2016

Last Update Submit

April 25, 2016

Conditions

Opiate Dependence

Keywords

Opioid AddictionAddictionDrug Dependence

Outcome Measures

Primary Outcomes (1)

  • 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.

    4 weeks

Secondary Outcomes (9)

  • Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)

    4 weeks

  • Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)

    4 weeks

  • Craving

    4 weeks

  • Illicit Drug Use, Measured by Urine Drug Testing

    4 weeks

  • Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire

    Day 9

  • +4 more secondary outcomes

Study Arms (1)

BUP/VLNXT to VIVITROL

EXPERIMENTAL

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.

Drug: very low dose naltrexoneDrug: extended release naltrexoneDrug: buprenorphine/naloxone

Interventions

very low dose naltrexoneDRUG

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.

BUP/VLNXT to VIVITROL
extended release naltrexoneDRUG

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.

Also known as: Vivitrol
BUP/VLNXT to VIVITROL
buprenorphine/naloxoneDRUG

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.

Also known as: Suboxone
BUP/VLNXT to VIVITROL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center / Civitan Building

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, AddictiveSubstance-Related Disorders

Interventions

NaltrexonevivitrolBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBuprenorphineDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Paolo Mannelli, M.D
Organization
Duke University Medical Center
paolo.mannelli@dm.duke.edu
919-681-0613

Study Officials

  • Paolo Mannelli, MD

    Duke University Health Systems

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 21, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 1, 2016

Results First Posted

June 1, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)