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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00975481
• Date of registration: 10/09/2009
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00975481
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Huntington's Disease

Alzheimer's Disease

Intervention(s)

Drug: dimebon

Drug: placebo

Drug: alprazolam

Primary Outcome(s)

Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax) [Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax) [Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 12, 24 hours post-dose]

Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax]) [Time Frame: 6, 12, 24 hours post-dose]

Other Subjective Effects- Drug Similarity [Time Frame: 12 hours post-dose]

Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax]) [Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax]) [Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax) [Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin) [Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) [Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax) [Time Frame: 6, 12, 24 hrs post-dose]

Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) [Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) [Time Frame: 6, 12, 24 hours post-dose]

Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax]) [Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin) [Time Frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax]) [Time Frame: 0.5, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose]

Secondary ID(s)

B1451037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medivation, Inc.

Results

• Results available: Yes
• Date Posted: 02/04/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00975481