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

Healthy Clinical Trial

— TC-5214  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01500018
• Other study ID #: D4130C00022
• Status: Withdrawn
• Phase: Phase 1
• First received: December 6, 2011
• Last updated: March 21, 2012
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Office of Controlled SubstanceUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug Abuse
• Healthy

Intervention

Drug:
• TC-5214
Single oral dose of 2 mg
• TC-5214 Placebo
Single oral dose
• Ketamine
Single oral dose of 100 mg
• Phentermine
Single oral dose of 45 mg
• TC-5214
Single oral dose of 8 mg
• TC-5214
Single oral dose of 16 mg
• Phentermine
Single oral dose of 90 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes