Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse

Completed · Phase 2

Conditions studied: Opioid Dependence

In brief

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.

Key facts

Study ID

NCT01967641

Run by

New York State Psychiatric Institute

People needed

51

Starts

2005-11-01

Expected to finish

2011-06-01

Last updated by the study team

2019-04-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV criteria for opioid abuse and prescription opioid physical dependence
• 18-65 years of age
• Stable weight (<10% change in 3 months) and stable physical health
• Chronic pain syndrome (e.g., osteoarthritic pain or chronic lower back pain with/without history of surgery) of moderate (4-7) average daily pain of 6+ months duration; opioid medication maintenance for 6+ months
• Seeking treatment for chronic pain
• Must be expected to achieve a good analgesic effect from buprenorphine

You may not qualify if…

• DSM-IV untreated Axis I disorders (e.g. MDD, BAD, psychotic disorders, eating disorders) requiring treatment
• Regular consumption of more than 500 mg caffeine daily
• Primary pain diagnosis of neuropathic pain, malignant pain, or headache
• History of allergy, adverse reaction, or sensitivity to opioids, including buprenorphine
• Pregnancy, lactation, or history of having given birth or had abortion or miscarriage within the last six months, or unwillingness to use an effective method of birth control (e.g. condoms, birth control pills, abstinence)
• Psychotropic medications which would potentially interfere with study procedures
• Inability to read or understand the self-report assessment forms unaided
• Use of medications known to interfere with buprenorphine metabolism, such as disulfiram, neuroleptics, azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and HIV protease inhibitors (e.g. ritonavir, indivair, and saquinavir)
• Methadone-dependent
• Current heroin dependence
• Current buprenorphine maintenance
• History of failed treatment with buprenorphine maintenance for pain
• Acute hepatitis with elevated liver function tests (i.e. AST and ALT > 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 <18.5 or > 35.0

Where it is running

• SURC — New York, New York, United States

Full record on ClinicalTrials.gov

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