NCT01500018

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 22, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

December 6, 2011

Last Update Submit

March 21, 2012

Conditions

Drug AbuseHealthy

Keywords

Phase Ihealthy recreational polydrug usersabuse liabilityTC-5214Single dose crossover study to evaluate the abuse potential of TC-5214

Outcome Measures

Primary Outcomes (1)

  • Momentary Drug Liking VAS maximum effect (Emax)

    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.

    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

Secondary Outcomes (34)

  • Momentary Drug Liking VAS minimum effect (Emin)

    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

  • Drug Liking VAS time-weighted mean (TWmean)

    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

  • Overall Drug Liking VAS maximum effect ( Emax)

    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

  • Overall Drug Liking VAS (Emin)

    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

  • Overall Drug Liking VAS 10-hour mean score

    0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose

  • +29 more secondary outcomes

Study Arms (14)

Crossover Treatment Sequence 1

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 2

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 3

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 4

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 5

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 6

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 7

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 8

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 9

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 10

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 11

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 12

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 13

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Crossover Treatment Sequence 14

EXPERIMENTAL

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-5214Drug: TC-5214 PlaceboDrug: KetamineDrug: Phentermine

Interventions

TC-5214DRUG

Single oral dose of 2 mg

Crossover Treatment Sequence 1Crossover Treatment Sequence 10Crossover Treatment Sequence 11Crossover Treatment Sequence 12Crossover Treatment Sequence 13Crossover Treatment Sequence 14Crossover Treatment Sequence 2Crossover Treatment Sequence 3Crossover Treatment Sequence 4Crossover Treatment Sequence 5Crossover Treatment Sequence 6Crossover Treatment Sequence 7Crossover Treatment Sequence 8Crossover Treatment Sequence 9
TC-5214 PlaceboDRUG

Single oral dose

Crossover Treatment Sequence 1Crossover Treatment Sequence 10Crossover Treatment Sequence 11Crossover Treatment Sequence 12Crossover Treatment Sequence 13Crossover Treatment Sequence 14Crossover Treatment Sequence 2Crossover Treatment Sequence 3Crossover Treatment Sequence 4Crossover Treatment Sequence 5Crossover Treatment Sequence 6Crossover Treatment Sequence 7Crossover Treatment Sequence 8Crossover Treatment Sequence 9
KetamineDRUG

Single oral dose of 100 mg

Crossover Treatment Sequence 1Crossover Treatment Sequence 10Crossover Treatment Sequence 11Crossover Treatment Sequence 12Crossover Treatment Sequence 13Crossover Treatment Sequence 14Crossover Treatment Sequence 2Crossover Treatment Sequence 3Crossover Treatment Sequence 4Crossover Treatment Sequence 5Crossover Treatment Sequence 6Crossover Treatment Sequence 7Crossover Treatment Sequence 8Crossover Treatment Sequence 9
PhentermineDRUG

Single oral dose of 45 mg

Crossover Treatment Sequence 1Crossover Treatment Sequence 10Crossover Treatment Sequence 11Crossover Treatment Sequence 12Crossover Treatment Sequence 13Crossover Treatment Sequence 14Crossover Treatment Sequence 2Crossover Treatment Sequence 3Crossover Treatment Sequence 4Crossover Treatment Sequence 5Crossover Treatment Sequence 6Crossover Treatment Sequence 7Crossover Treatment Sequence 8Crossover Treatment Sequence 9

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

KetaminePhentermine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAmphetaminesPhenethylaminesEthylaminesAmines

Study Officials

  • Hans A Eriksson, MD

    AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden

    STUDY DIRECTOR

  • Pierre Geoffroy, MDCM, MSC, FCFP

    Syneos Health

    PRINCIPAL INVESTIGATOR

  • Brendan Smyth, MD

    AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437

    STUDY DIRECTOR
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Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 26, 2011

Study Start

January 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

March 22, 2012

Record last verified: 2012-03