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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

Page last updated: August 23, 2015

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