NCT01587196

Brief Summary

The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

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

January 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2012

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

9 years

First QC Date

April 11, 2012

Results QC Date

May 7, 2024

Last Update Submit

October 9, 2024

Conditions

Prescription Opiate/Medication Dependence

Keywords

prescription opiates/medicationsvivitrolbrain imaging

Outcome Measures

Primary Outcomes (1)

  • Illicit-positive Urines During Treatment and Follow-up

    three months

Study Arms (1)

Naltrexone Intervention

EXPERIMENTAL

Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks.

Drug: Vivitrol

Interventions

VivitrolDRUG

There are monthly injections of depot naltrexone for 3 months.

Also known as: depot naltrexone (380 mg)
Naltrexone Intervention

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sign an informed consent form;
  • Be between the ages of 18 and 60;
  • Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI);
  • Be in good general health as determined by complete physical examination and laboratory tests;
  • Have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal.

You may not qualify if:

  • Current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
  • Current psychosis, dementia, mental retardation, or history of schizophrenia;
  • Significant clinical abnormalities in hematology, chemistry, or urinalysis;
  • Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
  • Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestrel implant); (Pregnancy testing will be done on all females of child bearing age); and
  • Current diagnosis of chronic pain disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Addiction Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Wang AL, Shi Z, Elman I, Langleben DD. Reduced cigarette smoking during injectable extended-release naltrexone treatment for opioid use disorder. Am J Drug Alcohol Abuse. 2020 Jul 3;46(4):472-477. doi: 10.1080/00952990.2020.1741001. Epub 2020 May 7.

    PMID: 32379516DERIVED

MeSH Terms

Interventions

vivitrol

Results Point of Contact

Title
Daniel Langleben, MD
Organization
University of Pennsylvania
langlebe@pennmedicine.upenn.edu
215-760-7067

Study Officials

  • Daniel Langleben, MD

    Co-Investigator

    PRINCIPAL INVESTIGATOR

  • Anna R Childress, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2012

First Posted

April 30, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

October 15, 2024

Results First Posted

October 15, 2024

Record last verified: 2024-10

Locations

US(1)