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

AstraZeneca

Status and phase: Withdrawn; Phase 1

Conditions: Healthy; Drug Abuse

Treatments: Drug: Ketamine; Drug: TC-5214; Drug: Phentermine; Drug: TC-5214 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01500018

D4130C00022

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 14 patient groups

Crossover Treatment Sequence 1

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 2

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 3

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 4

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 5

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 6

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 7

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 8

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 9

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 10

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 11

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 12

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 13

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214

Crossover Treatment Sequence 14

Experimental group

Description:

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

Treatment:

Drug: TC-5214 Placebo

Drug: Phentermine

Drug: Ketamine

Drug: TC-5214

Drug: Phentermine

Drug: TC-5214

Drug: TC-5214