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

Completed · Phase 1 · Has a placebo group

Conditions studied: Cocaine Abuse

In brief

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

Key facts

Study ID

NCT01366001

Run by

Alkermes, Inc.

People needed

33

Starts

2011-08-01

Expected to finish

2012-02-01

Last updated by the study team

2012-03-09

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Alkermes Study Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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