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

Prescription Opiate/Medication Dependence Clinical Trial

— fMRI CURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587196
• Other study ID #: 813953
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Prescription Opiate/Medication Dependence
• Recurrence

Intervention

Drug:
• Vivitrol
There are monthly injections of depot naltrexone for 3 months.

Locations

Country	Name	City	State
United States	University of Pennsylvania Addiction Treatment Research Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary drug use outcome is illicit-positive urines during treatment and follow-up.		Participants will be followed for an average of 6 months