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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease; Huntington's Disease

Treatments: Drug: placebo; Drug: dimebon; Drug: alprazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975481

B1451037

Details and patient eligibility

About

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

Full description

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

36 participants in 6 patient groups, including a placebo group

dimebon 20 mg

Experimental group

Treatment:

Drug: dimebon

Drug: dimebon

Drug: dimebon

dimebon 40 mg

Experimental group

Treatment:

Drug: dimebon

Drug: dimebon

Drug: dimebon

dimebon 60 mg

Experimental group

Treatment:

Drug: dimebon

Drug: dimebon

Drug: dimebon

placebo

Placebo Comparator group

Treatment:

Drug: placebo

alprazolam 1 mg

Active Comparator group

Treatment:

Drug: alprazolam

Drug: alprazolam

alprazolam 3 mg

Active Comparator group

Treatment:

Drug: alprazolam

Drug: alprazolam