Reinforcing Effects of Intranasal (IN) Buprenorphine Versus Buprenorphine/Naloxone

NCT01760473 | Completed Phase 3 Results

• 1 other identifier: #5879
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heroin Dependence

Keywords

opioid dependence

Outcome Measures

Primary Outcomes (1)

• Drug Self-administration

  The maximum number of responses (clicks on a computer mouse) the participant was willing to perform in order to receive a dose of the intranasal challenge drug under investigation.

  Throughout the testing sessions (approximately 9 weeks).

Secondary Outcomes (1)

• SOWS

  Throughout the testing sessions (approximately 9 weeks).

Study Arms (9)

Bup 8

EXPERIMENTAL

Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally.

Drug: Intranasal challenge drug

Bup 16

EXPERIMENTAL

Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally.

Drug: Intranasal challenge drug

Bup/Nal 8/2

EXPERIMENTAL

Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 2 mg of Naloxone.

Drug: Intranasal challenge drug

Bup/Nal 8/8

EXPERIMENTAL

Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 8 mg of Naloxone.

Drug: Intranasal challenge drug

Bup/Nal 8/16

EXPERIMENTAL

Intranasal challenge drug: 8 mg of Buprenorphine administered intranasally with 16 mg of Naloxone.

Drug: Intranasal challenge drug

Bup/Nal 16/4

EXPERIMENTAL

Intranasal challenge drug: 16 mg of Buprenorphine administered intranasally with 4 mg of Naloxone.

Drug: Intranasal challenge drug

Heroin

ACTIVE COMPARATOR

Intranasal challenge drug: 24 mg of heroin administered intranasally.

Drug: Intranasal challenge drug

Placebo

SHAM COMPARATOR

Intranasal challenge drug: Intranasal lactose powder.

Drug: Intranasal challenge drug

Naloxone 4 mg

ACTIVE COMPARATOR

Intranasal challenge drug: Intranasal Naloxone 4mg.

Drug: Intranasal challenge drug

Interventions

Intranasal challenge drug DRUG

Each of the experimental challenge drugs were administered intranasally to all participants in random order.

Bup 16; Bup 8; Bup/Nal 16/4; Bup/Nal 8/16; Bup/Nal 8/2; Bup/Nal 8/8; Heroin; Naloxone 4 mg; Placebo

Eligibility Criteria

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

You may qualify if:

• 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 opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (e.g., 1-2 bags of heroin per occasion at least twice per day)
• Self-administer IN buprenorphine above placebo levels during the qualification phase (see below)

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
• AST or 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
• Indivior Inc.: collaborator

Study Sites (1)

New York State Psychiatric Institute and Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heroin Dependence; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sandra Comer
• Organization: New York State Psychiatric Institute

sdc10@columbia.edu

646 774-6146

Study Officials

• Sandra Comer, PHD

  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

Model Details: In this study's design, all participants received each of the 9 intranasal test drugs under investigation. This study employed a Latin-square randomization procedure, therefore, the sequence of testing for the 9 intranasal drugs was unique for each participant.

Study Record Dates

• First Submitted: May 1, 2009
• First Posted: January 4, 2013
• Study Start: May 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 8, 2017
• Results First Posted: September 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)