Reducing the Abuse of Opioids in Drug Users
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|ClinicalTrials.gov Identifier: NCT03837860|
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : March 1, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Opioid Abuse, Unspecified Opioid Dependence||Drug: Oxycodone/Placebo Drug: Oxycodone/Risperidone Drug: Oxycodone/Ziprasidone||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Double-blinded, crossover study|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Reducing the Abuse Liability of Prescription Opioids in Recreational Drug Users: A Pilot Study|
|Estimated Study Start Date :||March 31, 2019|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 1, 2020|
Active Comparator: Oxycodone/Placebo
Each study participant will receive all three study interventions in random order.In this arm, the participant receives oxycodone or placebo
Oxycodone 20 mg plus placebo
Other Name: Oxycontin/Placebo
Active Comparator: Oxycodone/Risperidone
Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or risperidone
Oxycodone (20mg) plus Risperidone (2 mg)
Other Name: Oxycontin/Risperdal
Active Comparator: Oxycodone/Ziprasidone
Each study participant will receive all three study interventions in random order. In this arm the participant receives a combination of oxycodone or ziprasidone
Oxycodone (20mg) plus Ziprasidone (80 mg)
Other Name: Oxycontin/Geodon
- Change in Bipolar Visual Analog Scale (VAS) of Drug Likability [ Time Frame: Study visit 2 to study visit 6, an average of 10 days ]The bipolar VAS is used to measure the Change in magnitude of "drug liking". The Drug Effects Questionnaire AKA the bipolar VAS of Drug Likability is a 5 item self-administered assessment where participants place a mark on a line from 0 to 100, "strongly dislike" at 0 (on the left hand side), "no effect" at 50 (in the center) and "strongly like" at 100 (on the far right). Change from visit 2 to visit 6 will be measured.
- Change in Profile of Mood States (POMS) [ Time Frame: Study visit 2 to study visit 6, an average of 10 days ]POMS is a self-administered, standard validated psychological test formulated by McNair et al. (1971). It is a used to assess transient, distinct mood states. The questionnaire contains 65 words/statements that describe feelings people have. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.
- Change in Addiction Research Center Inventory Short Form (ARCI-SF) [ Time Frame: Study visit 2 to study visit 6, an average of 10 days ]The ARCI is a self-administered, standardized questionnaire for assessing subjective effects of psychoactive drugs that was developed in the early 1960s at the National Institute of Mental Health Addiction Research Center. For this study, we will be using the 49-item short form. Outcome will be assessed using categorical and continuous data analysis comparing across groups. Change from visit 2 to visit 6 will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837860
|Contact: Ameet Nagpal, MDemail@example.com|
|Contact: Grace Ihsiu Todd, MSNfirstname.lastname@example.org|
|Principal Investigator:||Ameet Nagpal, MD||UT Health San Antonio|