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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01500018
Recruitment Status : Withdrawn (Sponsor decision to withdraw.)
First Posted : December 26, 2011
Last Update Posted : March 22, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Drug Abuse Healthy Drug: TC-5214 Drug: TC-5214 Placebo Drug: Ketamine Drug: Phentermine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : January 2012
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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

  9. 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 ]
    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

  10. Subjective Drug Value Emax [ Time Frame: 10 and 24 hours post dose ]
    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.

  11. Subjective Drug Value 10 hour mean score [ Time Frame: 10 hours post dose ]
    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

  12. Subjective Drug 24 hour mean scores [ Time Frame: 10 and 24 hours post dose ]
    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

  13. High VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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.

  14. High VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  15. Good Effects VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  16. Good Effects VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  17. 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 ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  18. 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 ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  19. Bad Effects VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  20. Bad Effects VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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.

  21. 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 ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  22. 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 ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  23. 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 ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  24. 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 ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated

  25. 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 ]
    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

  26. Alertness/Drowsiness VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  27. Any Effects VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  28. Any Effects VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  29. Bowdle VAS Emax [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

  30. Bowdle VAS TWmean [ Time Frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose ]
    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

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

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

  33. 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 ]
    Questionnaire to assess possible addiction. The maximum value recorded is chosen

  34. 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 ]
    Questionnaire to assess possible addiction. The time-weighted mean value is calculated



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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).

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): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01500018     History of Changes
Other Study ID Numbers: D4130C00022
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

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
Chemically-Induced Disorders
Mental Disorders
Ketamine
Phentermine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Adrenergic Agents