Clinical trial NCT01587196: CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery
Official title: CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery - Prescription Opiates/Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prescription Opiate/Medication Dependence
Keywords: prescription opiates/medications
vivitrol
brain imaging
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Illicit-positive Urines During Treatment and Follow-up
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Addiction Treatment Research Center
state: Pennsylvania
Study officials:
affiliation: Co-Investigator
name: Daniel Langleben, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Principal Investigator
name: Anna R Childress, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.