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Trial record 9 of 74 for:    AMPHETAMINE AND DEXTROAMPHETAMINE

A Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users

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ClinicalTrials.gov Identifier: NCT03200080
Recruitment Status : Terminated (New Safety Information)
First Posted : June 27, 2017
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Biotie Therapies Inc.

Brief Summary:

This will be a single-dose, randomized, double-blind, active- and placebo-controlled, double dummy, 6-way crossover study to determine the abuse potential of tozadenant relative to d-amphetamine and placebo, when administered orally in healthy non-dependent, recreational polydrug users with stimulant experience, under fed conditions.

Each subject will participate in a medical Screening visit, a 4-day (3-night) qualification (drug discrimination) visit, six 3-day (2-night) treatment periods, and a follow-up visit.


Condition or disease Intervention/treatment Phase
Abuse Potential Drug: Tozadenant Drug: Placebo oral tablet Drug: d-amphetamine Drug: Placebo oral capsule Phase 1

Detailed Description:

The Qualification Phase will be conducted as a single, 4-day visit. Doses will be administered in a randomized, double-blind crossover manner following administration of a standard low-fat meal. Subjects will be dosed with 20 mg of d-amphetamine or matching placebo d-amphetamine on Day 1 and Day 2, approximately 24 hours apart. PD assessments will be conducted before dosing and at time points for up to 8 hours post dosing. Safety assessments will be conducted before dosing and for at least 24 hours following dosing. Data will be reviewed to determine subject eligibility.

The last drug administration in the Qualification Phase and the first drug administration in the Treatment Phase will be separated by a washout interval of at least 7 days and not to exceed 28 days.

During the Treatment Phase, there will be 6 treatment periods; subjects will receive a single oral dose of each of the following treatments with applicable matching oral placebos in a randomized, double-blind, double-dummy fashion following the administration of a standard, low-fat meal. The following treatments will be administered:

  • Treatment A: placebo (matched to tozadenant and d-amphetamine)
  • Treatment B: tozadenant 120 mg
  • Treatment C: tozadenant 240 mg
  • Treatment D: tozadenant 480 mg
  • Treatment E: d-amphetamine 20 mg
  • Treatment F: d-amphetamine 40 mg

Drug administration will occur on Day 1 of each of the 6 treatment periods. PD and PK assessments will be collected during the 24 hours post-dose and safety assessments will be collected during the 36 hours post-dose. Subjects will be discharged on Day 2, after approximately 36 hours post-dose, or remain at the clinical research unit longer (e.g., 48 hours or until the following morning) if there are safety concerns, at the discretion of the investigator or designee. Drug administration in each treatment period will be separated by a washout interval of at least 7 days after the last dose of study drug.

Subjects will return for an end-of-study safety Follow-up visit approximately 7 to 14 days after the subject's last study drug dose in the Treatment Phase or following early withdrawal.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double-Blind, 6-Way Crossover Study to Determine the Abuse Potential of Tozadenant Relative to D-Amphetamine and Placebo When Administered Orally in Healthy, Non-Dependent, Recreational Polydrug Users With Stimulant Experience, Under Fed Conditions
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Treatment A
Placebo oral tablet and Placebo oral capsule
Drug: Placebo oral tablet
2, 4, 6 or 8 Tozadenant matching placebo tablets

Drug: Placebo oral capsule
2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet

Experimental: Treatment B
Tozadenant 120 mg
Drug: Tozadenant
2, 4, 6 or 8 Tozadenant 60 mg tablets
Other Name: SYN115

Drug: Placebo oral capsule
2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet

Experimental: Treatment C
Tozadenant 240 mg
Drug: Tozadenant
2, 4, 6 or 8 Tozadenant 60 mg tablets
Other Name: SYN115

Drug: Placebo oral capsule
2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet

Experimental: Treatment D
Tozadenant 480 mg
Drug: Tozadenant
2, 4, 6 or 8 Tozadenant 60 mg tablets
Other Name: SYN115

Drug: Placebo oral capsule
2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet

Active Comparator: Treatment E
d-amphetamine 20 mg
Drug: Placebo oral tablet
2, 4, 6 or 8 Tozadenant matching placebo tablets

Drug: d-amphetamine
2 or 4 capsules, each containing 2 over-encapsulated d-amphetamine 5 mg tablets

Active Comparator: Treatment F
d-amphetamine 40 mg
Drug: Placebo oral tablet
2, 4, 6 or 8 Tozadenant matching placebo tablets

Drug: d-amphetamine
2 or 4 capsules, each containing 2 over-encapsulated d-amphetamine 5 mg tablets




Primary Outcome Measures :
  1. Drug Liking [ Time Frame: 24 hours ]
    Drug Liking Visual Analog Scale (VAS) ("at this moment"), assessed on a bipolar, 0- to 100-point visual analog scale.


Secondary Outcome Measures :
  1. Balance of effects [ Time Frame: 24 hours ]
    Based on Drug Liking VAS

  2. Global effects [ Time Frame: 24 hours ]
    Overall Drug Liking VAS

  3. Positive drug effects [ Time Frame: 24 hours ]
    High VAS

  4. Positive drug effects [ Time Frame: 24 hours ]
    Good Drug Effects VAS

  5. Negative drug effects [ Time Frame: 24 hours ]
    Bad Drug Effects VAS

  6. Stimulant effects [ Time Frame: 24 hours ]
    Alertness/Drowsiness VAS

  7. Stimulant effects [ Time Frame: 24 hours ]
    Agitation/Relaxation VAS

  8. Other drug effects: [ Time Frame: 24 hours ]
    Hallucinations VAS

  9. Other drug effects: [ Time Frame: 24 hours ]
    Detached VAS

  10. Other drug effects: [ Time Frame: 24 hours ]
    Addiction Research Center Inventory (ARCI)

  11. Other drug effects: [ Time Frame: 12 hours ]
    Drug Similarity VAS

  12. Other drug effects: [ Time Frame: 24 hours ]
    Bowdle VAS

  13. Cognitive and psychomotor effects [ Time Frame: 24 hours ]
    Divided Attention Test

  14. Cognitive and psychomotor effects [ Time Frame: 24 hours ]
    Choice Reaction Time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects 18 to 55 years of age, inclusive.
  • Have a body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 and a minimum weight of at least 50.0 kg
  • Current recreational polydrug users who self-report to:

    • Have used stimulants (e.g., amphetamines, cocaine, methylphenidate) for non-therapeutic purposes (i.e., for psychoactive effects) at least 10 times in the past year and at least 1 time in the 8 weeks before Screening.
    • Have at least 10 lifetime uses of drugs (e.g., opioids, sedatives) from at least 1 other class other than alcohol.
  • Agree to use an approved method of contraception
  • Be willing and able to abide by all study requirements and restrictions
  • Additional criteria may apply

Exclusion Criteria:

  • Substance or alcohol dependence within the past 2 years,
  • Clinically significant medical history or illness
  • Female subjects who have a positive pregnancy test, are currently pregnant or lactating, or who are planning to become pregnant within 30 days of last study drug administration.
  • Donation or loss of more than 500 mL whole blood within 30 days preceding the Screening visit.
  • Additional criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200080


Locations
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Canada, Ontario
INC Research Toronto, Inc.
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Biotie Therapies Inc.
Acorda Therapeutics
Investigators
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Principal Investigator: Michael McDonnell, MD INC Research Toronto

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Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT03200080     History of Changes
Other Study ID Numbers: TOZ-CL09
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amphetamine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors