Abuse Liability of Suboxone Versus Subutex

NCT00710385 | Completed Phase 3 Results

• 1 other identifier: 5518
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone.

Conditions

Opioid-related Disorders

Outcome Measures

Primary Outcomes (1)

• Drug's Breakpoint

  Measure of a drug's reinforcing effects. The "Breakpoint" is the point at which the participant stop performing an operant task (clicks on a mouse) in order to received the drug. Therefore, the reported breakpoint is the total amount of work the participant was willing to perform to receive the dose being tested

  Single measurement taken following each of the 7 IV experimental doses

Secondary Outcomes (1)

• Drug "Liking"

  Peak (highest) rating obtained following drug administration throughout the entire 3 hr session

Study Arms (7)

Heroin

ACTIVE COMPARATOR

Heroin 25 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: Heroin

Naloxone

ACTIVE COMPARATOR

Naloxone (NAL) .4 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: Naloxone

Low Bup Dose

EXPERIMENTAL

Combined dosing groups of (4 mg and 8mg of Buprenorphine) for participants who administered a maximum of 8 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: Low Bup Dose

Low Bup/Nal Dose

EXPERIMENTAL

Combined dosing groups of (4/1 mg and 8/2mg of Buprenorphine + Naloxone) for participants who administered a maximum of 8 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: Low Bup/Nal Dose

High Bup Dose

EXPERIMENTAL

Combined dosing groups of (8mg and 16mg of Bup) for participants who administered a maximum of 16 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: High Bup Dose

High Bup/Nal Dose

EXPERIMENTAL

Combined dosing groups of (8/2mg and 16/4mg of Buprenorphine + Naloxone) for participants who administered a maximum of 16 mg of Bup during the qualification phase. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: High Bup/Nal Dose

Placebo

PLACEBO COMPARATOR

Intravenous placebo (PCB) administration. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions.

Drug: Placebo (PCB)

Interventions

Heroin DRUG

Heroin (25 mg)

Also known as: Diacetylmorphine

Heroin

Naloxone DRUG

.4 mg

Also known as: Naloxone Hydrochloride (HCl)

Naloxone

Low Bup Dose DRUG

4 and 8 mg

Also known as: Subutex

Low Bup Dose

High Bup Dose DRUG

8mg and 16 mg

Also known as: Subutex

High Bup Dose

Low Bup/Nal Dose DRUG

Buprenorphine/Naloxone 4/1 mg, 8/2 mg

Also known as: Suboxone

Low Bup/Nal Dose

High Bup/Nal Dose DRUG

Buprenorphine/Naloxone 8/2 mg, 16/4 mg

Also known as: Suboxone

High Bup/Nal Dose

Placebo (PCB) DRUG

Placebo control administration

Also known as: 0 mg

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnostic and Statistical Manual (DSM) IV criteria for heroin dependence
• No major mood, psychotic, or anxiety disorder
• Physically healthy
• Able to perform study procedures
• years of age
• Normal body weight
• Current use of i.v. opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (1-2 bags of heroin per occasion at least twice per day)
• Self-administer at least 4 mg i.v. buprenorphine above placebo levels during the dose run up phase

You may not qualify if:

• DSM IV criteria for dependence on drugs other than opioids, nicotine or caffeine
• Participants requesting treatment
• Participants on parole or probation
• Pregnancy or lactation
• Birth, miscarriage or abortion within 6 months
• Current or recent history of significant violent behavior
• Current major Axis I psychopathology, other than opioid dependence (e.g., mood disorder with functional impairment or suicide risk, schizophrenia), that might interfere with ability to participate in the study
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limit of normal
• Significant suicide risk
• Current chronic pain
• Sensitivity, allergy, or contraindication to opioids
• Current or recent (past 30 days) physical dependence on or treatment with methadone, buprenorphine, or the buprenorphine/naloxone combination

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Schering-Plough: collaborator

Study Sites (1)

New York State Psychiatric Institute/Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Comer SD, Sullivan MA, Vosburg SK, Manubay J, Amass L, Cooper ZD, Saccone P, Kleber HD. Abuse liability of intravenous buprenorphine/naloxone and buprenorphine alone in buprenorphine-maintained intravenous heroin abusers. Addiction. 2010 Apr;105(4):709-18. doi: 10.1111/j.1360-0443.2009.02843.x.

  PMID: 20403021 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Heroin; Naloxone; Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The stringent criteria for enrollment, qualification and retention in this trial were highly selective for a certain subpopulation of opioid-dependent individuals.

Results Point of Contact

• Title: Sandra D. Comer
• Organization: Substance Abuse

sdc10@columbia.edu

646-774-6146

Study Officials

• Sandra D Comer, PhD

  Columbia University/New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: July 4, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 5, 2016
• Results First Posted: December 5, 2016

Record last verified: 2012-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)