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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Drug Abuse, Healthy

Intervention / Treatment
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* Drug: TC-5214
* Drug: TC-5214 Placebo
* Drug: Ketamine
* Drug: Phentermine
* Drug: TC-5214
* Drug: TC-5214
* Drug: Phentermine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossover Treatment Sequence 1<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 2<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 3<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 4<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 5<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 6<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 7<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 8<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 9<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 10<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 11<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 12<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 13<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|
| Experimental: Crossover Treatment Sequence 14<br>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<br>* Single oral dose of 2 mg<br>Drug: TC-5214 Placebo<br>* Single oral dose<br>Drug: Ketamine<br>* Single oral dose of 100 mg<br>Drug: Phentermine<br>* Single oral dose of 45 mg<br>Drug: TC-5214<br>* Single oral dose of 8 mg<br>Drug: TC-5214<br>* Single oral dose of 16 mg<br>Drug: Phentermine<br>* Single oral dose of 90 mg<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, healthy recreational polydrug users, abuse liability, TC-5214, Single dose crossover study to evaluate the abuse potential of TC-5214