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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01366001
First received: June 2, 2011
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Cocaine Abuse
Drug: ALKS 33-BUP
Drug: ALKS 33
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Multiple-dose, Parallel Group Study to Evaluate the Safety and Pharmacodynamic Effects of RDC-0313-buprenorphine (ALKS 33-BUP) Administered Alone and Co-administered With Cocaine to Opioid-experienced Cocaine Abusers

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • The primary outcome measures are safety and pharmacokinetics (PK)/ pharmacodynamics (PD) [ Time Frame: Study drug will be administered once daily for 10 consecutive days. ] [ Designated as safety issue: No ]
    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.


Enrollment: 33
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALKS 33-BUP Drug: ALKS 33-BUP
Sublingual administration, ALKS 33 + buprenorphine, administered once daily for 10 consecutive days.
Other Name: ALKS 33-BUP: RDC-0313 + buprenorphine.
Experimental: ALKS 33 Drug: ALKS 33
Sublingual administration, ALKS 33 administered once daily for 10 consecutive days.
Other Name: ALKS 33: RDC-0313.
Placebo Comparator: Placebo Drug: Placebo
Sublingual administration, Placebo administered once daily for 10 consecutive days.

Detailed Description:

There are no currently available pharmacologic treatments for cocaine abuse and/or dependence and the unmet medical need is growing. In collaboration with the National Institute on Drug Abuse (NIDA), Alkermes, Inc. is investigating a fixed-dose combination product consisting of ALKS 33 (also referred to as RDC-0313) and buprenorphine (ALKS 33-BUP) for the treatment of cocaine abuse and/or dependence (Grant Number R01DA031000).

This is a randomized, double-blind, placebo-controlled, parallel design inpatient study. Eligibility will be established which includes responses to cocaine infusions at baseline, prior to study drug administration. Approximately 30 opioid-experienced cocaine abusers will be randomized 1:1:1 to receive study drug. Study drug will be administered once daily for 10 consecutive days. Pharmacodynamic assessments and drug-drug interactions will be closely monitored during the study. Following study drug administration, subjects will receive cocaine infusions to evaluate the effect of treatment on the subjective effects and the PK/PD of cocaine. Subjects will be discharged from the clinical research unit 2 days after the last infusion of cocaine. Subjects will return for follow-up between 7 and 14 days after discharge. The full study will take subjects approximately 28 days, with 17 days of inpatient stay.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

In order to participate in the study, subjects must:

  1. Be volunteers who are not seeking treatment for drug addiction.
  2. Be between 21 and 50 years of age, inclusive.
  3. 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.
  4. 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.
  5. Have opioid experience within 3 years, and not physically dependent on opioids as confirmed by a naloxone challenge.
  6. 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.
  7. Have a medical history and physical examination that demonstrate no clinically significant contraindication for participating in the study.
  8. Pass qualification criteria for response to IV cocaine infusions.

Exclusion Criteria

In order to participate in the study, subjects must not:

  1. 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.
  2. 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.
  3. Present with symptoms of withdrawal following administration of the naloxone challenge test.
  4. Have a history of liver disease or current elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 3x the upper limit of normal.
  5. Have a history of allergy or hypersensitivity to opioid agonists (eg, buprenorphine) or opioid antagonists (eg, naltrexone, naloxone).
  6. Have a history of hepatitis C, or human immunodeficiency virus (HIV) types 1 and/or 2.
  7. 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.
  8. 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.
  9. If female, be currently pregnant or lactating or planning to become pregnant within 60 days of last study drug administration.
  10. Have any clinically significant history of cardiac disease, including cardiovascular and conduction abnormalities or electrocardiogram (ECG) evidence of cardiac abnormalities.
  11. Have used cocaine exclusively through the intranasal route.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366001

Locations
United States, Kansas
Alkermes Study Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Bernard L. Silverman, MD Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01366001     History of Changes
Other Study ID Numbers: ALK33BUP-101, R01DA031000
Study First Received: June 2, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
Opioid
Cocaine
Dependence
Abuse
Intravenous
Buprenorphine

Additional relevant MeSH terms:
Cocaine
Buprenorphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Analgesics, Opioid
Narcotics
Analgesics
Narcotic Antagonists

ClinicalTrials.gov processed this record on October 19, 2014