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OpenTrials
Completed

NCT Number: NCT01587196

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

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.

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Key information

Conditions

Prescription Opiate/Medication Dependence

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Pennsylvania Addiction Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vivitrol

Drug

There are monthly injections of depot naltrexone for 3 months.

Other names: depot naltrexone (380 mg)

Primary outcomes

  1. Illicit-positive Urines During Treatment and Follow-up

    Time frame: three months

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: fMRI CURE

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Apr 30, 2012
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.