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

AstraZeneca

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Conditions

Drug Abuse Healthy

Interventions

TC-5214DRUG

Single oral dose of 2 mg

TC-5214 PlaceboDRUG

Single oral dose

KetamineDRUG

Single oral dose of 100 mg

Phentermine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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Single oral dose of 45 mg

TC-5214DRUG

Single oral dose of 8 mg

TC-5214DRUG

Single oral dose of 16 mg

PhentermineDRUG

Single oral dose of 90 mg

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

Bowdle VAS TWmean

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose