Clinical trial NCT00975481: A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Huntington's Disease
Keywords: oral single-dose 6-way crossover recreational drug users abuse potential pharmacodynamics safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-09-11
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility 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.

Primary outcomes:
measure: Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
timeFrame: 6, 12, 24 hours post-dose
measure: Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])
timeFrame: 6, 12, 24 hours post-dose
measure: Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)
timeFrame: 6, 12, 24 hrs post-dose
measure: Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose
measure: Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])
timeFrame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
measure: Other Subjective Effects- Drug Similarity
timeFrame: 12 hours post-dose
measure: Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: