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

NCT00975481

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Official Title  ICMJE 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
Brief Summary Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).
Detailed Description The main purpose for this study is to determine whether dimebon exhibits abuse potential.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Alzheimer's Disease
  • Huntington's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2010)
36
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2009)
30
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00975481
Other Study ID Numbers  ICMJE B1451037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP