Phase 2
N=72
CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery
Prescription Opiate/Medication Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01587196 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Illicit-positive Urines During Treatment and Follow-up — 0; 0; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vivitrol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Illicit-positive Urines During Treatment and Follow-up |
0; 0; 1; 1; 70; 2 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01587196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.