Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214

This study has been withdrawn prior to enrollment.
(Sponsor decision to withdraw.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01500018
First received: December 6, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

This is a single dose, crossover study to assess the abuse potential of TC-5214 compared to placebo, ketamine, and phentermine in healthy recreational polydrug users.


Condition Intervention Phase
Drug Abuse
Healthy
Drug: TC-5214
Drug: TC-5214 Placebo
Drug: Ketamine
Drug: Phentermine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Momentary Drug Liking VAS maximum effect (Emax) [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.


Secondary Outcome Measures:
  • Momentary Drug Liking VAS minimum effect (Emin) [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking" The minimum value recorded is chosen.

  • Drug Liking VAS time-weighted mean (TWmean) [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "At this moment, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". Time weighted average score is calculated.

  • Overall Drug Liking VAS maximum effect ( Emax) [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The maximum value recorded is chosen.

  • Overall Drug Liking VAS (Emin) [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The minimum value recorded is chosen

  • Overall Drug Liking VAS 10-hour mean score [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.

  • Overall Drug Liking VAS 24-hour mean score [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "Overall, my liking for this drug is" with anchor points "0: Strong disliking" and "100: Strong liking". The mean value is calculated.

  • Take Drug Again VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.

  • Take Drug Again VAS 10-hour mean score [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated

  • Take Drug Again VAS 24-hour mean score [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I would take this drug again" with anchor points "0: Definitely not" and "100: Definitely so". The mean value is calculated

  • Subjective Drug Value Emax [ Time Frame: 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values.

  • Subjective Drug Value 10 hour mean score [ Time Frame: 10 hours post dose ] [ Designated as safety issue: Yes ]
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values

  • Subjective Drug 24 hour mean scores [ Time Frame: 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    The SDV is a proxy measure of reinforcing efficacy that involves a series of independent, theoretical forced choices between the drug administered and different monetary values

  • High VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen.

  • High VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling high" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated

  • Good Effects VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". The maximum value recorded is chosen

  • Good Effects VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel good drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated

  • Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  • Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  • Bad Effects VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen

  • Bad Effects VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel bad drug effects" with anchor points "0: Definitely not" and "100: Definitely so". Time weighted average score is calculated.

  • ARCI dysphoria scale (LSD) Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  • ARCI dysphoria scale (LSD) TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  • ARCI sedation scale (PCAG) Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  • ARCI sedation scale (PCAG) TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  • Alertness/Drowsiness VAS Emin (drowsiness) [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The minimum value recorded is chosen

  • Alertness/Drowsiness VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I am feeling" with anchor points "0: Very Drowsy" and "100: Very Alert". The time weighted mean value is calculated

  • Any Effects VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The maximum value recorded is chosen

  • Any Effects VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Visual analogue scale from 0 to 100 mm. The statement put is: "I can feel any drug effects" with anchor points "0: 0: Definitely not" and "100: 0: Definitely so". The time-weighted mean value is calculated

  • Bowdle VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The maximum value recorded is chosen

  • Bowdle VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    13 items for which the volunteer is asked to rate his/her feelings over the past 30 minutes. Each VAS will be scored from 0 to 100, with 0 reflecting "Not at all" and 100 reflecting "Extremely". The time-weighted mean value is calculated

  • ARCI A scale Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  • ARCI A scale TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  • ARCI Phentermine and Benzedrine Group scale (BG) Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  • ARCI Phentermine and Benzedrine Group scale (BG) TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ] [ Designated as safety issue: Yes ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated


Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover Treatment Sequence 1
Period 1: Placebo, Period 2: Phentermine 45 mg, Period 3: Phentermine 90 mg, Period 4: Ketamine 100 mg, Period 5: TC-5214 2 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 16 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 2
Period 1: Phentermine 45 mg, Period 2: Ketamine 100 mg , Period 3: Placebo, Period 4: TC-5214 8 mg , Period 5: Phentermine 90 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 2 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 3
Period 1: Ketamine 100 mg, Period 2: TC-5214 8 mg, Period 3: Phentermine 45 mg, Period 4: TC-5214 16 mg, Period 5: Placebo, Period 6: TC-5214 2 mg, Period 7: Phentermine 90 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 4
Period 1: TC-5214 8 mg, Period 2: TC-5214 16 mg, Period 3: Ketamine 100 mg, Period 4: TC-5214 2 mg, Period 5: Phentermine 45 mg , Period 6: Phentermine 90 mg, Period 7: Placebo
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 5
Period 1: TC-5214 16 mg, Period 2: TC-5214 2 mg, Period 3: TC-5214 8 mg, Period 4: Phentermine 90 mg, Period 5: Ketamine 100 mg, Period 6: Placebo , Period 7: Phentermine 45 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 6
Period 1: TC-5214 2 mg, Period 2: Phentermine 90 mg, Period 3: TC-5214 16 mg, Period 4: Placebo, Period 5: TC-5214 8 mg, Period 6:Phentermine 45 mg , Period 7: Ketamine 100 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 7
Period 1: Phentermine 90 mg, Period 2: Placebo, Period 3: TC-5214 2 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 16 mg, Period 6: Ketamine 100 mg, Period 7: TC-5214 8 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 8
Period 1: TC-5214 16 mg, Period 2: TC-5214 8 mg, Period 3: TC-5214 2 mg, Period 4: Ketamine 100 mg, Period 5: Phentermine 90 mg, Period 6: Phentermine 45 mg, Period 7: Placebo
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 9

Period 1: TC-5214 2 mg, Period 2: TC-5214 16 mg, Period 3: Phentermine 90 mg, Period 4: TC-5214 8 mg, Period 5: Placebo, Period 6: Ketamine 100 mg, Period 7:

Phentermine 45 mg

Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 10
Period 1: Phentermine 90 mg, Period 2: TC-5214 2 mg, Period 3: Placebo, Period 4: TC-5214 16 mg Ketamine 100 mg, Period 5: Phentermine 45 mg, Period 6: TC-5214 8 mg, Period 7: TC-5214 2 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 11
Period 1: Placebo, Period 2: Phentermine 90 mg, Period 3:Phentermine 45 mg, Period 4: TC-5214 2 mg, Period 5: Ketamine 100 mg, Period 6: TC-5214 16 mg, Period 7: TC-5214 8 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 12
Period 1: Phentermine 45 mg, Period 2: Placebo, Period 3: Ketamine 100 mg, Period 4:Phentermine 90 mg, Period 5: TC-5214 8 mg, Period 6: TC-5214 2 mg, Period 7: TC-5214 16 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 13
Period 1: Ketamine 100 mg, Period 2: Phentermine 45 mg, Period 3: TC-5214 8 mg, Period 4: Placebo, Period 5: TC-5214 16 mg, Period 6: Phentermine 90 mg, Period 7: TC-5214 2 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg
Experimental: Crossover Treatment Sequence 14
Period 1: TC-5214 8 mg, Period 2: Ketamine 100 mg, Period 3: TC-5214 16 mg, Period 4: Phentermine 45 mg, Period 5: TC-5214 2 mg, Period 6: Placebo, Period 7: Phentermine 90 mg
Drug: TC-5214
Single oral dose of 2 mg
Drug: TC-5214 Placebo
Single oral dose
Drug: Ketamine
Single oral dose of 100 mg
Drug: Phentermine
Single oral dose of 45 mg
Drug: TC-5214
Single oral dose of 8 mg
Drug: TC-5214
Single oral dose of 16 mg
Drug: Phentermine
Single oral dose of 90 mg

Detailed Description:

A Single-center, Single-dose, Double-blind, Randomized, Placebo- and Active-controlled Crossover Study to Evaluate the Abuse Potential of TC-5214 in Healthy Recreational Polydrug Users.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Current recreational polydrug users with experience with at least 2 drug classes of abuse.
  • At least 10 lifetime uses of stimulants drugs (eg, amphetamine, cocaine, methamphetamine) and 10 lifetime occasions of recreational use of psychedelic drugs (eg, cannabis, ketamine, dextromethorphan, PCP, MDMA [ecstasy], LSD, mesacline, or psilocybin).
  • Recreational use of other classes of drugs is permitted, including opioids (eg, codeine, morphine, or heroin), minor tranquilizers, or sedatives (eg, benzodiazepines or barbiturates).
  • Male or female volunteers aged 18 to 55, inclusive with a body mass index (BMI) within the range of 19.0 to 33.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening.
  • Must pass qualification phase eligibility criteria.

Exclusion Criteria:

  • Self-reported history of drug or alcohol dependence (except caffeine) in the past 12 months, including subjects who have ever been in a drug rehabilitation program (other than treatment for smoking cessation).
  • Unwillingness or inability to abstain from recreational drug use for the duration of the study from screening until follow-up.
  • Positive for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening.
  • Any significant unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or any other medical conditions that might confound the study or put the volunteer at greater risk during study participation.
  • Currently smoking more than 20 cigarettes (or 2 cigars) per day, and/or unwillingness to abstain from smoking for durations of at least 12 hours.
  • Use of tobacco cessation product within 1 month (eg, nicotine substitution products, bupropion, etc).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500018

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans A Eriksson, MD AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden
Principal Investigator: Pierre Geoffroy, MDCM, MSC, FCFP INC Research
Study Director: Brendan Smyth, MD AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01500018     History of Changes
Other Study ID Numbers: D4130C00022
Study First Received: December 6, 2011
Last Updated: March 21, 2012
Health Authority: Canada: Health Canada
Canada: Office of Controlled Substance
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
healthy recreational polydrug users
abuse liability
TC-5214
Single dose crossover study to evaluate the abuse potential of TC-5214

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Phentermine
Ketamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on April 22, 2014