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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy; Drug Abuse
• Intervention / Treatment: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine; Drug: TC-5214; Drug: TC-5214; Drug: Phentermine

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
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

14

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Momentary Drug Liking VAS minimum effect (Emin)	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.	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)	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.	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)	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.	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Overall Drug Liking VAS (Emin)	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	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	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.	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
Overall Drug Liking VAS 24-hour mean score	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.	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Take Drug Again VAS Emax	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.	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Take Drug Again VAS 10-hour mean score	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
Take Drug Again VAS 24-hour mean score	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Subjective Drug Value Emax	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.	10 and 24 hours post dose
Subjective Drug Value 10 hour mean score	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	10 hours post dose
Subjective Drug 24 hour mean scores	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	10 and 24 hours post dose
High VAS Emax	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.	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
High VAS TWmean	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Good Effects VAS Emax	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Good Effects VAS TWmean	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax	Questionnaire to assess possible addiction. The maximum value recorded is chosen	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean	Questionnaire to assess possible addiction. The time-weighted mean value is calculated	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bad Effects VAS Emax	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bad Effects VAS TWmean	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.	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI dysphoria scale (LSD) Emax	Questionnaire to assess possible addiction. The maximum value recorded is chosen	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI dysphoria scale (LSD) TWmean	Questionnaire to assess possible addiction. The time-weighted mean value is calculated	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI sedation scale (PCAG) Emax	Questionnaire to assess possible addiction. The maximum value recorded is chosen	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI sedation scale (PCAG) TWmean	Questionnaire to assess possible addiction. The time-weighted mean value is calculated	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Alertness/Drowsiness VAS Emin (drowsiness)	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Alertness/Drowsiness VAS TWmean	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Any Effects VAS Emax	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Any Effects VAS TWmean	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bowdle VAS Emax	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bowdle VAS TWmean	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	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI A scale Emax	Questionnaire to assess possible addiction. The maximum value recorded is chosen	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI A scale TWmean	Questionnaire to assess possible addiction. The time-weighted mean value is calculated	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI Phentermine and Benzedrine Group scale (BG) Emax	Questionnaire to assess possible addiction. The maximum value recorded is chosen	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI Phentermine and Benzedrine Group scale (BG) TWmean	Questionnaire to assess possible addiction. The time-weighted mean value is calculated	0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Hans A Eriksson, MD, AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden; Principal Investigator: Pierre Geoffroy, MDCM, MSC, FCFP, Syneos Health; Study Director: Brendan Smyth, MD, AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): April 1, 2012
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 23, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): March 22, 2012
• Last Update Submitted That Met QC Criteria: March 21, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: abuse liability; Phase I; healthy recreational polydrug users; TC-5214; Single dose crossover study to evaluate the abuse potential of TC-5214
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Ketamine; Phentermine
• Other Study ID Numbers: D4130C00022