Phase 2
N=51
Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01967641 ↗Enrolled (actual)
51
Serious AEs
13.7%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants Retained in Study — 18 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- buprenorphine/naloxone combination (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Retained in Study |
18 | — |
| SECONDARY Number of Participants Abstinent From Opioids |
17 | — |
| SECONDARY Pain Measurement |
6.1; 4.3 | — |
Summary
In this study, we will assess opioid self-administration in a laboratory setting in persons with pain who have a history of opioid abuse. Participants diagnosed with mild to moderate pain will be admitted to hospital for 7 weeks and transitioned from their baseline prescription opioid to a standing daily dose of Suboxone (buprenorphine/naloxone combination). During this maintenance period, participants will have the opportunity in a laboratory setting to self-administer oxycodone; subjective responses as well as analgesic, physiological and performance effects will be measured. In the second phase of this study, the same patients who participated in the inpatient phase will be followed on an outpatient basis while maintained on Suboxone for 12 weeks. . The hypotheses of this study are that (1) higher progressive ratio break-point values for oxycodone, higher subjective ratings of euphoria, and less pain relief will predict early relapse to opioid abuse; (2) the abuse liability measures will be more strongly correlated with relapse than the pain measures; (3) subjective ratings of euphoria will increase and of pain will decrease in an oxycodone dose-dependent manner (i.e. euphoria will increase and pain will decrease as dose increases); and (4) experimentally induced pain will decrease in an oxycodone dose-dependent manner.
Eligibility Criteria
Inclusion Criteria
- DSM-IV criteria for opioid abuse and prescription opioid physical dependence
- 18-65 years of age
- Stable weight ( 3 times the upper limit of normal) or impaired renal function (creatinine > 1.2 )
- Any medical condition that might interfere with the study or significantly increase the medical risks of study participation
- Participant is currently receiving any investigational drug or has used any investigational drug within 30 days of study entry
- History of significant cardiovascular disease, such as coronary artery disease or hypertension requiring more than two anti-hypertensive agents
- History of insulin-dependent diabetes
- Body mass index of 35.0
Data sourced from ClinicalTrials.gov (NCT01967641). 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.