Drug Abuse, Healthy
Conditions
Keywords
Phase I, healthy recreational polydrug users, abuse liability, TC-5214, Single dose crossover study to evaluate the abuse potential of TC-5214
Brief summary
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
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.
Interventions
DRUGTC-5214
Single oral dose of 2 mg
DRUGTC-5214 Placebo
Single oral dose
DRUGKetamine
Single oral dose of 100 mg
DRUGPhentermine
Single oral dose of 45 mg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Momentary Drug Liking VAS maximum effect (Emax) | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Momentary Drug Liking VAS minimum effect (Emin) | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| ARCI dysphoria scale (LSD) Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The maximum value recorded is chosen |
| Drug Liking VAS time-weighted mean (TWmean) | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| Overall Drug Liking VAS maximum effect ( Emax) | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| Overall Drug Liking VAS (Emin) | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Overall Drug Liking VAS 10-hour mean score | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose | 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. |
| Overall Drug Liking VAS 24-hour mean score | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| Take Drug Again VAS Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| Take Drug Again VAS 10-hour mean score | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose | 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 |
| Take Drug Again VAS 24-hour mean score | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Subjective Drug Value Emax | 10 and 24 hours post dose | 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. |
| Subjective Drug Value 10 hour mean score | 10 hours post dose | 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 |
| Subjective Drug 24 hour mean scores | 10 and 24 hours post dose | 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 |
| High VAS Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| High VAS TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Good Effects VAS Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Bad Effects VAS TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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. |
| Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The maximum value recorded is chosen |
| Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The time-weighted mean value is calculated |
| Bad Effects VAS Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| ARCI dysphoria scale (LSD) TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The time-weighted mean value is calculated |
| ARCI sedation scale (PCAG) Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The maximum value recorded is chosen |
| ARCI sedation scale (PCAG) TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The time-weighted mean value is calculated |
| Alertness/Drowsiness VAS Emin (drowsiness) | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Alertness/Drowsiness VAS TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Any Effects VAS Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Any Effects VAS TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Bowdle VAS Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| Bowdle VAS TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
| ARCI A scale Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The maximum value recorded is chosen |
| ARCI A scale TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The time-weighted mean value is calculated |
| ARCI Phentermine and Benzedrine Group scale (BG) Emax | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The maximum value recorded is chosen |
| ARCI Phentermine and Benzedrine Group scale (BG) TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | Questionnaire to assess possible addiction. The time-weighted mean value is calculated |
| Good Effects VAS TWmean | 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose | 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 |
Outcome results
None listed