A Study To Evaluate The Abuse Potential 0f Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease; Huntington's Disease
Intervention: dimebon (Drug); dimebon (Drug); dimebon (Drug); placebo (Drug); alprazolam (Drug); alprazolam (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Summary
Dimebon will not exhibit abuse potential when compared to placebo or a positive control
(alprazolam).
Clinical Details
Official title: A Randomized, Double-Blind, Placebo- And Active-Controlled Single-Dose, Crossover Study To Evaluate The Abuse Potential 0f Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Study design: Other, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Balance of Effects:
• Drug Liking VAS maximum (Emax) and minimum (Emin) effect.
• Overall Drug Liking VAS Emax and Emin.
• Take Drug Again VAS Emax.
• Good and Bad Effects VAS Emax and Emin.
• SDV Emax.Positive Effects:
• ARCI (MBG) Emax.
• Good Drug Effects VAS Emax.
• High VAS Emax. Negative Effects:
• Bad Drug Effects VAS Emax.
• ARCI (LSD) Emax. Sedative Effects:
• ARCI (PCAG) Emax.
• Alertness/Drowsiness VAS Emin. Other Subjective Effects:
• Any Drug Effects VAS Emax.
• Drug Similarity VAS (mean scores).
• ARCI (BG) Emax and Emin.
Secondary outcome: Safety: assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy male and/or female subjects between the ages of 18 and 55 years.
- Recreational polydrug user with a history of CNS depressant use.
Exclusion Criteria:
- History of clinically significant neurologic condition(s), such as seizures,
convulsions, epilepsy, or significant head injury, as judged by the investigator or
designee.
- A known history of hypersensitivity or previous intolerance to dimebon or other
antihistamines.
- Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in
the 2 years prior to screening, or drug or alcohol dependence as defined by the
(DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in
a substance rehabilitation program (other than treatment for smoking cessation).
- History of clinically significant psychiatric disorder(s), as judged by the
investigator or qualified designee.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021 Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2009
Ending date: February 2010
Last updated: October 6, 2009
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