WithdrawnPhase 1ketamine

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

Sponsored by AstraZeneca

NCT ID
NCT01500018
Start Date
2012-01
Est. Completion
2012-04

About This Study

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.

Conditions Studied

Drug AbuseHealthy

Interventions

  • TC-5214
  • TC-5214 Placebo
  • Ketamine
  • Phentermine
  • TC-5214
  • TC-5214
  • Phentermine

Eligibility

Age:18 Years - 55 Years
Healthy Volunteers:Yes
View full eligibility 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).

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source