Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse (PAIN)
Opioid Dependence
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, opioid abuse, suboxone, prescription pain medications
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- SURC
Arms of the Study
Arm 1
Experimental
buprenorphine/naloxone combination
Buprenorphine/naloxone (Bup/Nx; Suboxone sublingual tablets, Reckitt Benckiser) will be administered sublingually at daily doses of 2/0.5, 8/2 mg, and 16/4 mg, which are within the recommended dose range for treating both pain and opioid abuse. The total daily dose will be divided and administered on a QID dosing regimen (0.5/0.125, 2/0.5, and 4/1 mg QID at 0830, 1230, 1730, 2130). Each participant will be tested with all three doses in random order for two weeks at each dose (one week of stabilization followed by one week of testing). Following completion of the 7-week inpatient phase, participants will be followed at the Substance Use Research Center (SURC) and maintained on 16/4 mg Bup/Nx.