NCT02187198

Brief Summary

Buprenorphine/naloxone (BUP/NLX) treatment is effective for the treatment of prescription opioid dependence, previous studies have not determined the optimum dose of BUP/NLX for this patient population. The goal of this study is to determine if there are differences in clinical efficacy of BUP/NLX tablet in low dose range (less than or equal to 8/2mg) vs. high dose range (greater than or equal to 16, range 16-24mg). The main outcomes of interest will be treatment retention, use of opioids, and the use of other drugs of abuse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

6.9 years

First QC Date

July 8, 2014

Results QC Date

January 27, 2023

Last Update Submit

March 8, 2023

Conditions

Opioid Dependence

Keywords

Opioid DependenceBuprenorphine

Outcome Measures

Primary Outcomes (2)

  • Urine Toxicology for Opiate Use

    Will be used to document opioid use, a urine toxicology screening will be completed weekly during study participation (12 week study)

    Weeks 1-12

  • Urine Toxicology

    Will be used to document cannabinoid use, a urine toxicology screening will be completed weekly during study participation (12 week study)

    Weeks 1-12

Study Arms (2)

Buprenorphine low dose

EXPERIMENTAL

Participants in this arm will receive a low dose (less than or equal to 8/2mg) of buprenorphine for 12 weeks.

Drug: Buprenorphine

Buprenorphine high dose

EXPERIMENTAL

Participants in this arm will receive a high dose (16-24mg) of buprenorphine for 12 weeks.

Drug: Buprenorphine

Interventions

BuprenorphineDRUG
Also known as: Naloxone, Suboxone, Buprenex, Subutex
Buprenorphine high doseBuprenorphine low dose

Eligibility Criteria

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

You may qualify if:

  • Males and females between the ages of 18 to 65, current dependence on prescription opioids as evidenced by documented prior treatment for opioid dependence, signs of opiate withdrawal as evidenced by a Clinical Opiate Withdrawal Scale score of 7 or greater, self-reported history of opioid dependence, and a positive urine toxicology for opiates;
  • willingness to be detoxified from opioids for buprenorphine maintenance ;
  • for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy, with monthly pregnancy tests obtained during study participation.

You may not qualify if:

  • use of heroin for more than 4 days in the past month;
  • lifetime history of opioid dependence due to heroin alone;
  • ever used heroin intravenously;
  • requirement for current ongoing opioid treatment for adequate pain management;
  • current alcohol, benzodiazepine, barbiturate use with physiologic dependence as determined during screening history and physical,
  • serious unstable medical illness including bradycardia or other arrhythmias, major cardiovascular, renal, endocrine, or hepatic disorders for which buprenorphine treatment is contraindicated or which at the determination of the MD is medically dangerous;
  • serious psychiatric illness including psychosis, bipolar disorder with psychosis:
  • or significant current suicidal or homicidal thoughts necessitating a higher level or care;
  • known allergy or intolerance to buprenorphine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System - West Haven Campus

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

BuprenorphineNaloxoneBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Elizabeth Ralevski, PhD
Organization
Yale University School of Medicine, Department of Psychiatry
elizabeth.ralevski@yale.edu
203-932-5711

Study Officials

  • Elizabeth Ralevski, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

March 1, 2015

Primary Completion

February 1, 2022

Study Completion

January 1, 2023

Last Updated

March 10, 2023

Results First Posted

March 10, 2023

Record last verified: 2023-03

Locations

US(1)