A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 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: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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 Of Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax]) Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax) Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax) Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax]) Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax]) Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax]) Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax) Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax) Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin) Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax]) Other Subjective Effects- Drug Similarity Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)
Detailed description:
The main purpose for this study is to determine whether dimebon exhibits abuse potential.
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
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: October 2009
Last updated: February 20, 2013
|