A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

Official Title: “A Randomized, Double-Blind, Placebo- And Active-Controlled Single-Dose, Crossover Study To Evaluate The Abuse Potential Of Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users”

Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).

The main purpose for this study is to determine whether dimebon exhibits abuse potential.

Intervention(s) in this Clinical Trial

• Drug: dimebon
  • Oral tablet; 20 mg dimebon, single dose
• Drug: dimebon
  • Oral tablet; 40 mg dimebon, single dose
• Drug: dimebon
  • Oral tablet; 60 mg dimebon, single dose
• Drug: placebo
  • Oral tablet or capsule; placebo, single dose
• Drug: alprazolam
  • Oral capsule; 1 mg alprazolam, single dose
• Drug: alprazolam
  • Oral capsule; 3 mg alprazolam, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: dimebon 20 mg
• Experimental: dimebon 40 mg
• Experimental: dimebon 60 mg
• Placebo Comparator: placebo
• Active Comparator: alprazolam 1 mg
• Active Comparator: alprazolam 3 mg

Primary Measures

• 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.
  • Time Frame: Day 1
    Safety Issue?: No
• Positive Effects: • ARCI (MBG) Emax. • Good Drug Effects VAS Emax. • High VAS Emax.
  • Time Frame: Day 1
    Safety Issue?: No
• Negative Effects: • Bad Drug Effects VAS Emax. • ARCI (LSD) Emax.
  • Time Frame: Day 1
    Safety Issue?: No
• Sedative Effects: • ARCI (PCAG) Emax. • Alertness/Drowsiness VAS Emin.
  • Time Frame: Day 1
    Safety Issue?: No
• Other Subjective Effects: • Any Drug Effects VAS Emax. • Drug Similarity VAS (mean scores). • ARCI (BG) Emax and Emin.
  • Time Frame: Day 1
    Safety Issue?: No

Secondary Measures

• 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.
  • Time Frame: Day 1, Follow-up
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00975481

Study ID Number: B1451037

ClinicalTrials.gov Identifier: NCT00975481

Health Authority: Canada: Health Canada

To obtain contact information for a study center near you, click here.