Drug AbusePhase 1TC-5214NCT01500018

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

A Phase 1 study testing TC-5214, Ketamine and Phentermine in people with Drug Abuse and Healthy, run by AstraZeneca.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Drug Abuse, Healthy
What is being tested?: TC-5214, Ketamine and Phentermine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Jan 2012to Apr 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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).

About this study

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

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.

Read the 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.

Conditions: Drug Abuse, Healthy
Being tested: TC-5214, TC-5214 Placebo, Ketamine, Phentermine
Keywords: Phase I, healthy recreational polydrug users, abuse liability, TC-5214, Single dose crossover study to evaluate the abuse potential of TC-5214
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TC-5214Drug
Single oral dose of 2 mg
TC-5214 PlaceboDrug
Single oral dose
KetamineDrug
Single oral dose of 100 mg
PhentermineDrug
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

Study groups in NCT01500018
Study group	Role	What they receive
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine
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 Receives: Drug: TC-5214; Drug: TC-5214 Placebo; Drug: Ketamine; Drug: Phentermine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (34)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Apr 2012

First posted26 Dec 2011 (estimated)
Study startJan 2012
Primary completionApr 2012 (estimated)
Study completionApr 2012 (estimated)

Why it stopped: Sponsor decision to withdraw.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Drug AbuseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01500018
Sponsor's protocol ID: D4130C00022
Acronym: TC-5214
Status last verified: Mar 2012
First submitted: 6 Dec 2011
Last updated: 22 Mar 2012
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Drug Abuse trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01500018
Acronym / sponsor ID: TC-5214 / D4130C00022
Conditions: Drug Abuse, Healthy
Keywords: Phase I, healthy recreational polydrug users, abuse liability, TC-5214, Single dose crossover study to evaluate the abuse potential of TC-5214
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Sponsor decision to withdraw.
Enrolment: 0 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Apr 2012 (estimated)
Study completion: Apr 2012 (estimated)
First posted: 26 Dec 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 14

Arm	Type	Receives
Crossover Treatment Sequence 1	Experimental	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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
Crossover Treatment Sequence 5	Experimental	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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	Drug: TC-5214, Drug: TC-5214 Placebo, Drug: Ketamine, Drug: PhenterminePeriod 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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TC-5214Single oral dose of 2 mg	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9
TC-5214 PlaceboSingle oral dose	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9
KetamineSingle oral dose of 100 mg	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9
PhentermineSingle oral dose of 45 mg	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9
TC-5214Single oral dose of 8 mg	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9
TC-5214Single oral dose of 16 mg	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9
PhentermineSingle oral dose of 90 mg	Drug	Crossover Treatment Sequence 1, Crossover Treatment Sequence 10, Crossover Treatment Sequence 11, Crossover Treatment Sequence 12, Crossover Treatment Sequence 13, Crossover Treatment Sequence 14, Crossover Treatment Sequence 2, Crossover Treatment Sequence 3, Crossover Treatment Sequence 4, Crossover Treatment Sequence 5, Crossover Treatment Sequence 6, Crossover Treatment Sequence 7, Crossover Treatment Sequence 8, Crossover Treatment Sequence 9

Primary outcome

Momentary Drug Liking VAS maximum effect (Emax)
Time frame: 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.

34 secondary outcomes

Momentary Drug Liking VAS minimum effect (Emin)
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)
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)
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)
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
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
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
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
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
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Subjective Drug Value Emax
Time frame: 10 and 24 hours post dose
Subjective Drug Value 10 hour mean score
Time frame: 10 hours post dose
Subjective Drug 24 hour mean scores
Time frame: 10 and 24 hours post dose
High VAS Emax
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
High VAS TWmean
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Good Effects VAS Emax
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Good Effects VAS TWmean
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
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
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bad Effects VAS Emax
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bad Effects VAS TWmean
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
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
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
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
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)
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Alertness/Drowsiness VAS TWmean
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Any Effects VAS Emax
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Any Effects VAS TWmean
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Bowdle VAS Emax
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
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
ARCI A scale TWmean
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
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
Time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hans A Eriksson, MD study director

AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden

Pierre Geoffroy, MDCM, MSC, FCFP principal investigator

Syneos Health

Brendan Smyth, MD study director

AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TC-5214, Ketamine and Phentermine in people with Drug Abuse and Healthy, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Momentary Drug Liking VAS maximum effect (Emax) (time frame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01500018.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.