Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214
NCT ID: NCT01500018
Last Updated: 2012-03-22
Study Results
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Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2012-01-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
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
TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
Interventions
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TC-5214
Single oral dose of 2 mg
TC-5214 Placebo
Single oral dose
Ketamine
Single oral dose of 100 mg
Phentermine
Single oral dose of 45 mg
TC-5214
Single oral dose of 8 mg
TC-5214
Single oral dose of 16 mg
Phentermine
Single oral dose of 90 mg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
55 Years
ALL
Yes
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Hans A Eriksson, MD
Role: STUDY_DIRECTOR
AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden
Pierre Geoffroy, MDCM, MSC, FCFP
Role: PRINCIPAL_INVESTIGATOR
Syneos Health
Brendan Smyth, MD
Role: STUDY_DIRECTOR
AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437
Other Identifiers
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D4130C00022
Identifier Type: -
Identifier Source: org_study_id
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