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

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ClinicalTrials.gov Identifier: NCT00975481
Recruitment Status : Completed
First Posted : September 11, 2009
Results First Posted : April 2, 2013
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 10, 2009
First Posted Date  ICMJE September 11, 2009
Results First Submitted Date  ICMJE December 3, 2012
Results First Posted Date  ICMJE April 2, 2013
Last Update Posted Date April 2, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2013)
  • 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 ]
    Drug liking VAS is one of the measures of balance of effects that assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar visual analogue scale (VAS) anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm). Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 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 ]
    Overall drug liking VAS is one of the measures of balance of effects that assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carryover effects). A 100 mm bipolar VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm= "neither like nor dislike", and 100 mm= "strong liking"). Emax is the largest effect score between 6 to 24 hours post-dose. Emin is the smallest effect score between 6 to 24 hours post-dose.
  • Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax]) [ Time Frame: 6, 12, 24 hours post-dose ]
    Take drug again VAS is one of the measures of balance of effects. It is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm bipolar VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely not", 50 mm = "do not care", and 100 mm = "definitely so"). Emax is largest effect score between 6 hours to 24 hours.
  • 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 ]
    Good and Bad effects VAS is one of the measures of balance of effects that assesses the effect experienced by the participant on a 100 mm bipolar VAS, anchored in the center with a neutral anchor of neither good nor bad effects (score of 50 mm), on the left with bad effects(score of 0 mm) and on the right with good effects (score of 100 mm). Emax is largest effect score between 0.5 to 24 hours post-dose. Emin is smallest effect score between 0.5 to 24 hours post-dose.
  • Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax) [ Time Frame: 6, 12, 24 hrs post-dose ]
    SDV is one of measures of balance of effects. It is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between drug administered and different monetary values. Participants were asked to choose between receiving another dose of same drug or an envelope containing specified amount of money, but they did not receive drug or money as described. Possible score range from 0.25 to 50. Higher score range indicates higher SDV. Emax: largest effect score between 6-24 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 ]
    ARCI (MBG) is one of the measures of positive effects. It is a set of 16 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to the scoring direction. Score range: 0 to 16, higher score indicated positive effects. Emax: largest effect score between 0 to 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 ]
    Good drug effects VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is the largest effect score between 0.5 to 24 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 ]
    High VAS is one of the measures of positive effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is largest effect score between 0 to 24 hours.
  • 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 ]
    Bad effects VAS is one of the measures of negative effects that assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is largest effect score between 0.5 to 24 hrs.
  • 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 ]
    ARCI (LSD) is one of the measures of negative effects. It is a set of 14 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when the answer is opposite to scoring direction. Score range: 0 to 14, higher score indicated higher negative effects. Emax: largest effect score between 0 to 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 ]
    ARCI (PCAG) is one of the measures of sedative effects. It is a set of 15 questions in which each question contributes to total score. Participants indicate their responses by selecting 'False' or 'True'. One point is given for each response that agrees with the scoring direction on scale i.e, true items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'. No points are given when answer is opposite to scoring direction. Score range: 0 to 15, higher score indicated higher sedative effects. Emax: largest effect score between 0 to 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 ]
    Alertness/Drowsiness VAS is one of the measures of sedative effects. It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither drowsy nor alert" (score of 50 mm), on the left with "very drowsy" (score of 0 mm) and on the right with "very alert" (score of 100 mm). Emin is the smallest effect score between 0 to 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 ]
    Any drug effects VAS is one of the measures of other subjective effects. It assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= definitely not) to 'extremely' (score of 100 mm= definitely so). Emax is the largest effect score between 0.5 to 24 hours post-dose.
  • Other Subjective Effects- Drug Similarity [ Time Frame: 12 hours post-dose ]
    Drug similarity VAS is one of the measures of other subjective effects. It assesses the similarity of the drug recently received by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm= not at all similar) to 'extremely' (score of 100 mm= very similar). Recently received drugs were compared with placebo, benzodiazepines, codeine/morphine, Tetrahydrocannabinol (THC), pseudoephedrine.
  • 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 ]
    ARCI (BG) is measure of other subjective effects. It is a set of 13 questions in which each question contributes to total score. Participants select 'False' / 'True' for response. One point given for each response that agrees with scoring direction, true items receive score of 1 if answer 'True', false items receive score of 1 if answer 'False'. No points if answer is opposite to scoring direction. Score range: 0 to 13, higher score indicated higher other subjective effects. Emax: largest effect score between 0 - 24 hours post-dose. Emin: smallest effect score between 0 - 24 hours post-dose.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
  • Balance of Effects: • Drug Liking VAS maximum (Emax) and minimum (Emin) effect. • Overall Drug Liking VAS Emax and Emin. • Take Drug Again VAS Emax. • Good and Bad Effects VAS Emax and Emin. • SDV Emax. [ Time Frame: Day 1 ]
  • Positive Effects: • ARCI (MBG) Emax. • Good Drug Effects VAS Emax. • High VAS Emax. [ Time Frame: Day 1 ]
  • Negative Effects: • Bad Drug Effects VAS Emax. • ARCI (LSD) Emax. [ Time Frame: Day 1 ]
  • Sedative Effects: • ARCI (PCAG) Emax. • Alertness/Drowsiness VAS Emin. [ Time Frame: Day 1 ]
  • Other Subjective Effects: • Any Drug Effects VAS Emax. • Drug Similarity VAS (mean scores). • ARCI (BG) Emax and Emin. [ Time Frame: Day 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2009)
Safety: assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring. [ Time Frame: Day 1, Follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Alzheimer's Disease
  • Huntington's Disease
Intervention  ICMJE
  • Drug: dimebon
    Oral tablet; 20 mg dimebon, single dose
  • Drug: dimebon
    Oral tablet; 40 mg dimebon, single dose
  • Drug: dimebon
    Oral tablet; 60 mg dimebon, single dose
  • Drug: placebo
    Oral tablet or capsule; placebo, single dose
  • Drug: alprazolam
    Oral capsule; 1 mg alprazolam, single dose
  • Drug: alprazolam
    Oral capsule; 3 mg alprazolam, single dose
Study Arms  ICMJE
  • Experimental: dimebon 20 mg
    Intervention: Drug: dimebon
  • Experimental: dimebon 40 mg
    Intervention: Drug: dimebon
  • Experimental: dimebon 60 mg
    Intervention: Drug: dimebon
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: alprazolam 1 mg
    Intervention: Drug: alprazolam
  • Active Comparator: alprazolam 3 mg
    Intervention: Drug: alprazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2010)
36
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2009)
30
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00975481
Other Study ID Numbers  ICMJE B1451037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Medivation, Inc.
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP