CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery (fMRI CURE)

April 19, 2021 updated by: University of Pennsylvania

CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery - Prescription Opiates/Medication

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Addiction Treatment Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Sign an informed consent form;
  2. Be between the ages of 18 and 60;
  3. Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI);
  4. Be in good general health as determined by complete physical examination and laboratory tests;
  5. 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.

Exclusion Criteria:

  1. Current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
  2. Current psychosis, dementia, mental retardation, or history of schizophrenia;
  3. Significant clinical abnormalities in hematology, chemistry, or urinalysis;
  4. Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
  5. 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
  6. Current diagnosis of chronic pain disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Naltrexone Intervention
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
There are monthly injections of depot naltrexone for 3 months.
Other Names:
  • depot naltrexone (380 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary drug use outcome is illicit-positive urines during treatment and follow-up.
Time Frame: Participants will be followed for an average of 6 months
Participants will be followed for an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Investigators

  • Principal Investigator: Anna R Childress, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 813953

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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