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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
ClinicalTrials.gov_[email protected]
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease, Huntington's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00975481
Pfizer
Completed
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users

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A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
  • Alzheimer's Disease
  • Huntington's Disease
  • 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
  • Experimental: dimebon 20 mg
    Intervention: Drug: dimebon
  • Experimental: dimebon 40 mg
    Intervention: Drug: dimebon
  • Experimental: dimebon 60 mg
    Intervention: Drug: dimebon
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: alprazolam 1 mg
    Intervention: Drug: alprazolam
  • Active Comparator: alprazolam 3 mg
    Intervention: Drug: alprazolam
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
February 2010
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada
 
NCT00975481
B1451037
No
Not Provided
Not Provided
Pfizer
Pfizer
Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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