Clinical trial NCT03837860: Reducing the Abuse of Opioids in Drug Users
Official title: Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Opioid Abuse, Unspecified
Opioid Dependence
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded, crossover study
Primary purpose: PREVENTION

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 abused class of substances in the United States. Moreover, patients who take pain medications for legitimate reasons may develop an opioid use disorder (OUD), with as many as 1 in 4 patients becoming dependent on their pain medications. Because of changing access to prescription opioid analgesics due to an increasingly negative prescribing climate and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain patients trying heroin within 10 years. Pain is a symptom that can be severely debilitating and needs to be treated adequately to improve the quality of life. Clinicians, then, are in a proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them to medications with substantial abuse liability and overdose risk. In this proposal, a method aimed at reducing the abuse potential of prescription opioid medications, without altering their analgesic efficacy, is described.

The study team hypothesize that this can be accomplished by administering a fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or capsule.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Bipolar Visual Analog Scale (VAS) of Drug Likability
timeFrame: Study visit 2 to study visit 6, an average of 10 days
Secondary outcomes:
measure: Change in Profile of Mood States (POMS)
timeFrame: Study visit 2 to study visit 6, an average of 10 days
measure: Change in Addiction Research Center Inventory Short Form (ARCI-SF)
timeFrame: Study visit 2 to study visit 6, an average of 10 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Westgate Pain Clinic
state: Texas
Study officials:
affiliation: UT Health San Antonio
name: Ameet Nagpal, MD
role: PRINCIPAL_INVESTIGATOR
References: