Clinical trial NCT01500018: Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Momentary Drug Liking VAS maximum effect (Emax)
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Secondary outcomes:
measure: Momentary Drug Liking VAS minimum effect (Emin)
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Drug Liking VAS time-weighted mean (TWmean)
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Overall Drug Liking VAS maximum effect ( Emax)
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Overall Drug Liking VAS (Emin)
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Overall Drug Liking VAS 10-hour mean score
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
measure: Overall Drug Liking VAS 24-hour mean score
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Take Drug Again VAS Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Take Drug Again VAS 10-hour mean score
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8 and 10 hours post dose
measure: Take Drug Again VAS 24-hour mean score
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Subjective Drug Value Emax
timeFrame: 10 and 24 hours post dose
measure: Subjective Drug Value 10 hour mean score
timeFrame: 10 hours post dose
measure: Subjective Drug 24 hour mean scores
timeFrame: 10 and 24 hours post dose
measure: High VAS Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: High VAS TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Good Effects VAS Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Good Effects VAS TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Bad Effects VAS Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Bad Effects VAS TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI dysphoria scale (LSD) Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI dysphoria scale (LSD) TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI sedation scale (PCAG) Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI sedation scale (PCAG) TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Alertness/Drowsiness VAS Emin (drowsiness)
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Alertness/Drowsiness VAS TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Any Effects VAS Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Any Effects VAS TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Bowdle VAS Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: Bowdle VAS TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI A scale Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI A scale TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI Phentermine and Benzedrine Group scale (BG) Emax
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
measure: ARCI Phentermine and Benzedrine Group scale (BG) TWmean
timeFrame: 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca Kvzmbergagatan 12, 15185,Sodertalje, Sweden
name: Hans A Eriksson, MD
role: STUDY_DIRECTOR
affiliation: Syneos Health
name: Pierre Geoffroy, MDCM, MSC, FCFP
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca 180 Concord Pike, Wilmington,DE 19850-5437
name: Brendan Smyth, MD
role: STUDY_DIRECTOR
References: