Phase 1
N=36
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Alzheimer's Disease · Huntington's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00975481 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) — 57.8; 78.6; 82.2; 57.2 mm — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- dimebon (Drug); placebo (Drug); alprazolam (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) |
57.8; 78.6; 82.2; 57.2; 55.8; 58.5 | <0.0001 sig |
| PRIMARY Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) |
57.8; 74.6; 78.0; 56.5; 55.4; 58.1 | <0.0001 sig |
| PRIMARY Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax]) |
53.9; 77.5; 83.2; 47.6; 50.4; 52.5 | <0.0001 sig |
| PRIMARY Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin) |
56.2; 80.9; 81.9; 57.9; 56.6; 57.6 | <0.0001 sig |
| PRIMARY Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax) |
4.805; 19.621; 25.551; 6.098; 3.836; 4.573 | <0.0001 sig |
| PRIMARY Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax) |
3.2; 6.2; 8.1; 3.5; 3.6; 3.5 | <0.0001 sig |
| PRIMARY Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax]) |
35.2; 81.2; 84.7; 34.4; 32.0; 39.7 | <0.0001 sig |
| PRIMARY Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax]) |
30.4; 77.1; 88.0; 25.9; 29.9; 35.8 | <0.0001 sig |
| PRIMARY Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax]) |
17.2; 33.9; 44.6; 15.9; 16.8; 19.7 | 0.0016 sig |
| PRIMARY Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax) |
3.8; 4.9; 7.0; 3.8; 3.8; 3.6 | 0.0005 sig |
| PRIMARY Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax) |
4.7; 9.9; 11.5; 5.3; 5.5; 5.5 | <0.0001 sig |
| PRIMARY Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin) |
42.1; 14.4; 8.6; 42.9; 37.7; 38.5 | <0.0001 sig |
| PRIMARY Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax]) |
37.2; 84.0; 88.7; 37.5; 33.4; 44.4 | <0.0001 sig |
| PRIMARY Other Subjective Effects- Drug Similarity |
56.3; 10.2; 4.0; 61.4; 57.8; 55.7 | <0.0001 sig |
| PRIMARY Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin) |
6.3; 6.6; 7.2; 6.5; 6.3; 6.4 | 0.1691 |
Summary
Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).
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.
Data sourced from ClinicalTrials.gov (NCT00975481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.