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

NCT ID: NCT01587196

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2021-01-01

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.

Conditions

Prescription Opiate/Medication Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vivitrol

Intervention Type: DRUG

There are monthly injections of depot naltrexone for 3 months.

Interventions

Vivitrol

There are monthly injections of depot naltrexone for 3 months.

Intervention Type: DRUG

Other Intervention Names

depot naltrexone (380 mg)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Langleben, MD

Role: PRINCIPAL_INVESTIGATOR

Co-Investigator

Anna R Childress, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

University of Pennsylvania Addiction Treatment Research Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32379516 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

813953

Identifier Type: -

Identifier Source: org_study_id