Status:
TERMINATED
Reducing the Abuse of Opioids in Drug Users
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Opioid Abuse, Unspecified
Opioid Dependence
Eligibility:
All Genders
21-65 years
Phase:
EARLY_PHASE1
Brief Summary
The consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. Opioid analgesics remain among the most commonly ab...
Eligibility Criteria
Inclusion
- Adult patients between 21 to 65 years of age, capable of understanding and providing consent in English, and capable of complying with the outcome instruments used.
- Recreational opioid use (i.e. defined as prescription opioid use for nontherapeutic purposes on at least 10 occasions within the previous year and at least once in the 12 weeks prior to screening)
- Reported tolerated doses to opioid medications
Exclusion
- Currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or past history of major psychiatric disorder such as bipolar disorder/psychosis
- Presence of dementia
- Current neuroleptic medication in past 30 days
- Pregnancy
- Positive drug urine test for Barbiturates, Benzodiazepines, Methadone, and Buprenorphine.
- Subjects with a prolonged QT interval greater than 430ms (i.e. QTc \>430ms)
- Subjects with a heart rate of less than 60 or greater than 100bpm will be assessed by a physician for symptomatic bradycardia/tachycardia and eligibility determined on a case-by-case basis
- Subjects with serum potassium and/or magnesium outside of normal range of our institutional laboratory within the past three months from time of screening.
- Subjects who appears intoxicated on the day of study visit by an on-site physician.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03837860
Start Date
April 1 2019
End Date
January 21 2022
Last Update
February 15 2022
Active Locations (1)
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1
Westgate Pain Clinic
San Antonio, Texas, United States, 78229