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Sponsor decision to withdraw.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover Treatment Sequence 1 | Experimental | 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 |
|
| Crossover Treatment Sequence 2 | Experimental | 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 |
|
| Crossover Treatment Sequence 3 | Experimental | 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 |
|
| Crossover Treatment Sequence 4 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5214 | Drug | Single oral dose of 2 mg |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans A Eriksson, MD | AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden | Study Director |
| Pierre Geoffroy, MDCM, MSC, FCFP | Syneos Health | Principal Investigator |
| Brendan Smyth, MD | AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437 | Study Director |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D010645 | Phentermine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Crossover Treatment Sequence 5 | Experimental | 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 |
|
| Crossover Treatment Sequence 6 | Experimental | 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 |
|
| Crossover Treatment Sequence 7 | Experimental | 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 |
|
| Crossover Treatment Sequence 8 | Experimental | 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 |
|
| Crossover Treatment Sequence 9 | Experimental | 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 |
|
| Crossover Treatment Sequence 10 | Experimental | 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 |
|
| Crossover Treatment Sequence 11 | Experimental | 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 |
|
| Crossover Treatment Sequence 12 | Experimental | 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 |
|
| Crossover Treatment Sequence 13 | Experimental | 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 |
|
| Crossover Treatment Sequence 14 | Experimental | 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 Placebo | Drug | Single oral dose |
|
| Ketamine | Drug | Single oral dose of 100 mg |
|
| Phentermine | Drug | Single oral dose of 45 mg |
|
| TC-5214 | Drug | Single oral dose of 8 mg |
|
| TC-5214 | Drug | Single oral dose of 16 mg |
|
| Phentermine | Drug | Single oral dose of 90 mg |
|
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |