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

Primary Purpose

Prescription Opiate/Medication Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vivitrol
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prescription Opiate/Medication Dependence focused on measuring prescription opiates/medications, vivitrol, brain imaging

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Pennsylvania Addiction Treatment Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Naltrexone Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

The primary drug use outcome is illicit-positive urines during treatment and follow-up.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2012
Last Updated
April 19, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01587196
Brief Title
CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery
Acronym
fMRI CURE
Official Title
CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery - Prescription Opiates/Medication
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Opiate/Medication Dependence
Keywords
prescription opiates/medications, vivitrol, brain imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vivitrol
Other Intervention Name(s)
depot naltrexone (380 mg)
Intervention Description
There are monthly injections of depot naltrexone for 3 months.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Langleben, MD
Organizational Affiliation
Co-Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna R Childress, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Addiction Treatment Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32379516
Citation
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. Erratum In: Am J Drug Alcohol Abuse. 2020 Jul 3;46(4):512.
Results Reference
derived

Learn more about this trial

CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery

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