ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine

NCT01366001 | Completed Phase 1 DMC

• 2 other identifiers: ALK33BUP-101R01DA031000
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.

Conditions

Cocaine Abuse

Keywords

Opioid; Cocaine; Dependence; Abuse; Intravenous; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• The primary outcome measures are safety and pharmacokinetics (PK)/ pharmacodynamics (PD)

  For safety, the primary outcome measures are AEs and cardiovascular responses (Heart Rate, Blood Pressure, Electrocardiogram) collected during cocaine infusions at baseline and during treatment with ALKS 33-BUP, ALKS 33 and placebo.

  Study drug will be administered once daily for 10 consecutive days.

Study Arms (3)

ALKS 33-BUP

EXPERIMENTAL

Drug: ALKS 33-BUP

ALKS 33

EXPERIMENTAL

Drug: ALKS 33

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ALKS 33-BUP DRUG

Sublingual administration, ALKS 33 + buprenorphine, administered once daily for 10 consecutive days.

Also known as: ALKS 33-BUP: RDC-0313 + buprenorphine.

ALKS 33-BUP

ALKS 33 DRUG

Sublingual administration, ALKS 33 administered once daily for 10 consecutive days.

Also known as: ALKS 33: RDC-0313.

ALKS 33

Placebo DRUG

Sublingual administration, Placebo administered once daily for 10 consecutive days.

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to participate in the study, subjects must:
• Be volunteers who are not seeking treatment for drug addiction.
• Be between 21 and 50 years of age, inclusive.
• Have a body mass index (BMI) within the range of 18.0 to 30.0 kilograms per square meter (kg/m2), inclusive, and a minimum weight of at least 50.0 kilograms(kg) at screening.
• Have experience using cocaine by the smoked or IV route within the past year, and a positive urinary drug screen for cocaine prior to study intake.
• Have opioid experience within 3 years, and not physically dependent on opioids as confirmed by a naloxone challenge.
• Be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures, prior to the initiation of any protocol-specific procedures.
• Have a medical history and physical examination that demonstrate no clinically significant contraindication for participating in the study.
• Pass qualification criteria for response to IV cocaine infusions.

You may not qualify if:

• In order to participate in the study, subjects must not:
• Have a current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder. Have any previous clinically significant reaction to cocaine, including loss of consciousness or seizure.
• Other than drug abuse, have any history of clinically significant major psychiatric illness (eg, severe mood disorder, psychotic disorders ) according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision(DSM IV-TR)criteria or disorders secondary to drug use in the opinion of the investigator.
• Present with symptoms of withdrawal following administration of the naloxone challenge test.
• Have a history of liver disease or current elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 3x the upper limit of normal.
• Have a history of allergy or hypersensitivity to opioid agonists (eg, buprenorphine) or opioid antagonists (eg, naltrexone, naloxone).
• Have a history of hepatitis C, or human immunodeficiency virus (HIV) types 1 and/or 2.
• Have a positive urine drug screen upon screening for drugs other than cocaine (or bioequivalent metabolite), marijuana (tetrahydrocannabinol, THC), or due to their long-elimination half-life, benzodiazepines.
• Have a positive alcohol test at screening or at admission to the inpatient phase of the study. If a subject presents with positive alcohol test, the subject can be rescheduled at the discretion of the sponsor and the investigator or designee.
• If female, be currently pregnant or lactating or planning to become pregnant within 60 days of last study drug administration.
• Have any clinically significant history of cardiac disease, including cardiovascular and conduction abnormalities or electrocardiogram (ECG) evidence of cardiac abnormalities.
• Have used cocaine exclusively through the intranasal route.

Sponsors & Collaborators

• Alkermes, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Alkermes Study Site

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bernard L. Silverman, MD

  Alkermes, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 3, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

US (1)