NCT01733693

Brief Summary

The purpose of this study is to (1) compare the effects of buprenorphine and methadone, two types of opioid addiction treatment, on the ability to think and reason among people addicted to opiates, and who are either HIV negative or HIV positive; and (2) investigate whether HIV infection changes the way opioid treatment affects the ability to think and reason. The investigators hypothesize that there will be (1) significant improvement in thinking and reasoning ability after starting buprenorphine treatment compared to methadone treatment, among participants with and without HIV at 2 and 4 months compared to baseline; and (2) HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 2 and 4 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 14, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4.4 years

First QC Date

November 14, 2012

Last Update Submit

January 28, 2022

Conditions

Opioid-Related DisordersHIVHIV Infections

Keywords

BuprenorphineMethadoneCognition

Outcome Measures

Primary Outcomes (2)

  • Global Neurocognitive Function

    Metrics: A Global Deficit Score (GDS) is computed by adding deficit ratings of the component test measures, and dividing by total number of measures. (Please see list of component test measures under the Domain-Specific Neurocognitive Function outcome).

    2 and 4 months

  • Domain-Specific Neurocognitive Function (i.e. in the domains of executive functioning, learning, memory, attention/working memory, processing speed, motor, and verbal functioning).

    Metrics: Domain Deficit Scores (DDS) are created for each of the 7 cognitive ability domains. Deficit Scores can be analyzed as dichotomous variables to classify individual subjects as impaired or normal, or continuously. Executive Functioning -- Wisconsin Card Sorting Task-64 Item Version; Trail Making Test (Part B) Learning -- Hopkins Verbal Learning Test-Revised (Total Recall); Brief Visuospatial Memory Test-Revised (Total Recall) Memory -- Hopkins Verbal Learning Test (Delayed Recall Trial); Brief Visuospatial Memory Test-Revised (Delayed Recall Trial) Attention/Working Memory -- WAIS-III Letter Number Sequencing; PASAT Total Correct Processing Speed -- WAIS-III Digit Symbol; WAIS-III Symbol Search; Trail Making Test (Part A) Motor -- Grooved Pegboard Time (dominant hand); Grooved Pegboard Time (non-dominant hand)\] Verbal Functioning -- Controlled Oral Word Association Test (F-A-S); Semantic (Animal) Fluency

    2 and 4 months

Study Arms (2)

Buprenorphine

EXPERIMENTAL

Oral sublingual tablet, 8-32 mg per day, administered daily for duration of 4 months

Drug: Buprenorphine

Methadone

ACTIVE COMPARATOR

Oral sublingual tablet, 60-100 mg per day, administered daily for duration of 4 months

Drug: Methadone

Interventions

BuprenorphineDRUG

Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator). We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.

Also known as: Buprenorphine HCl
Buprenorphine
MethadoneDRUG

Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator). We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.

Also known as: Methadone Hydrochloride
Methadone

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 68
  • English or Spanish speaking
  • Documentation of HIV Status
  • Opioid-dependent without having received medication treatment for opioid dependence within the previous 90 days
  • Negative pregnancy test, for women
  • No "street" use of methadone or buprenorphine
  • Willing to participate in all study components
  • Able to provide informed consent
  • Education \> 6 years
  • Not acutely intoxicated

You may not qualify if:

  • Serious or unstable medical disease: liver disease (AST or ALT ≥ 3x ULN, elevated PT/INR, albumin \<3.0 g/dl or evidence of decompensated cirrhosis);
  • Severe cardiovascular disease (MI, PTCA, unstable angina, CABG, and/or serious arrhythmia in the previous 6 months);
  • COPD (requiring supplemental oxygen or hospitalization in past 6 months);
  • End stage renal disease or creatinine clearance \<30 mL/min
  • Neurological disease: head injury with LOC\>24 hour, previous penetrating skull wound, focal brain lesion, history of neurosurgery, seizure disorder (not ETOH-related), non-HIV CNS opportunistic infection
  • Psychiatric disorders (schizophrenia or bipolar)
  • Benzodiazepine or alcohol dependence
  • Chronic pain conditions requiring opioid analgesics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fordham University

The Bronx, New York, 10458, United States

Location

Albert Einstein College of Medicine of Yeshiva University

The Bronx, New York, 10467, United States

Location

Related Publications (1)

  • Scott TM, Arnsten J, Olsen JP, Arias F, Cunningham CO, Rivera Mindt M. Neurocognitive, psychiatric, and substance use characteristics in a diverse sample of persons with OUD who are starting methadone or buprenorphine/naloxone in opioid treatment programs. Addict Sci Clin Pract. 2021 Oct 24;16(1):64. doi: 10.1186/s13722-021-00272-4.

    PMID: 34689841DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersHIV Infections

Interventions

BuprenorphineMethadone

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsKetonesOrganic Chemicals

Study Officials

  • Julia Arnsten, MD, MPH

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 27, 2012

Study Start

January 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

February 11, 2022

Record last verified: 2022-01

Locations

US(2)