Prescription Opioid Abuse Among Pain Patients: Predictors of Relapse

NCT01967641 | Completed Phase 2 Results DMC

• 2 other identifiers: #6269RDA020448-05
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Dependence

Keywords

opioid dependence; opioid abuse; suboxone; prescription pain medications

Outcome Measures

Primary Outcomes (1)

• Number of Participants Retained in Study

  Retention was number of participants retained at study end (Week 19).

  week 19

Secondary Outcomes (2)

• Number of Participants Abstinent From Opioids

  at week 19 or length of study participation

• Pain Measurement

  assessed twice weekly during course of 19 weeks or length of participation, only screening and last assessment reported.

Study Arms (1)

buprenorphine/naloxone combination

EXPERIMENTAL

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.

Drug: buprenorphine/naloxone combination

Interventions

buprenorphine/naloxone combination DRUG

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 maintained on 16/4 mg Bup/Nx.

Also known as: Suboxone

buprenorphine/naloxone combination

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV criteria for opioid abuse and prescription opioid physical dependence
• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

SURC

New York, New York, 10032, United States

Location

Related Links

• The Substance Treatment and Research Service of Columbia University (STARS) provides free and confidential treatment of substance abuse in the context of a research treatment clinical trial.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Maria A. Sullivan, M.D., Ph.D
• Organization: New York State Psychiatric Institute

mas23@columbia.edu

646-774-6152

Study Officials

• Maria Sullivan, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Following induction, patients were stabilized beginning on Day 2 on one of three blinded doses of buprenorphine/naloxone (2/0.5, 8/2, or 16/4 mg per day) for a week then underwent laboratory testing for a second week. Each blinded buprenorphine dose was administered in equal divided doses according to a QID dosing schedule, and each dose was maintained for a two-week period, with the second week including laboratory testing.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: November 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 24, 2019
• Results First Posted: June 15, 2018

Record last verified: 2019-04

Locations

US (1)