Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214
- Conditions
- Drug AbuseHealthy
- Interventions
- Registration Number
- NCT01500018
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Crossover Treatment Sequence 9 TC-5214 Placebo 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 Crossover Treatment Sequence 9 TC-5214 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 Crossover Treatment Sequence 6 TC-5214 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 Crossover Treatment Sequence 9 Ketamine 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 Crossover Treatment Sequence 9 Phentermine 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 Crossover Treatment Sequence 10 TC-5214 Placebo 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 Crossover Treatment Sequence 5 TC-5214 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 Crossover Treatment Sequence 10 Ketamine 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 Crossover Treatment Sequence 5 TC-5214 Placebo 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 Crossover Treatment Sequence 13 Phentermine 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 Crossover Treatment Sequence 14 TC-5214 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 Crossover Treatment Sequence 14 TC-5214 Placebo 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 Crossover Treatment Sequence 6 TC-5214 Placebo 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 Crossover Treatment Sequence 6 Ketamine 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 Crossover Treatment Sequence 6 Phentermine 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 Crossover Treatment Sequence 7 TC-5214 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 Crossover Treatment Sequence 7 TC-5214 Placebo 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 Crossover Treatment Sequence 11 TC-5214 Placebo 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 Crossover Treatment Sequence 1 TC-5214 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 Crossover Treatment Sequence 1 TC-5214 Placebo 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 Crossover Treatment Sequence 1 Phentermine 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 Crossover Treatment Sequence 2 TC-5214 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 Crossover Treatment Sequence 2 TC-5214 Placebo 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 Crossover Treatment Sequence 2 Ketamine 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 Crossover Treatment Sequence 12 TC-5214 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 Crossover Treatment Sequence 12 TC-5214 Placebo 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 Crossover Treatment Sequence 12 Ketamine 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 Crossover Treatment Sequence 7 Phentermine 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 Crossover Treatment Sequence 8 TC-5214 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 Crossover Treatment Sequence 13 TC-5214 Placebo 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 Crossover Treatment Sequence 8 TC-5214 Placebo 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 Crossover Treatment Sequence 8 Ketamine 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 Crossover Treatment Sequence 13 TC-5214 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 Crossover Treatment Sequence 3 TC-5214 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 Crossover Treatment Sequence 3 TC-5214 Placebo 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 Crossover Treatment Sequence 3 Phentermine 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 Crossover Treatment Sequence 4 TC-5214 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 Crossover Treatment Sequence 4 TC-5214 Placebo 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 Crossover Treatment Sequence 10 TC-5214 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 Crossover Treatment Sequence 11 TC-5214 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 Crossover Treatment Sequence 1 Ketamine 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 Crossover Treatment Sequence 2 Phentermine 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 Crossover Treatment Sequence 3 Ketamine 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 Crossover Treatment Sequence 4 Phentermine 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 Crossover Treatment Sequence 4 Ketamine 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 Crossover Treatment Sequence 5 Ketamine 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 Crossover Treatment Sequence 5 Phentermine 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 Crossover Treatment Sequence 7 Ketamine 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 Crossover Treatment Sequence 8 Phentermine 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 Crossover Treatment Sequence 10 Phentermine 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 Crossover Treatment Sequence 11 Ketamine 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 Crossover Treatment Sequence 11 Phentermine 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 Crossover Treatment Sequence 12 Phentermine 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 Crossover Treatment Sequence 14 Ketamine 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 Crossover Treatment Sequence 13 Ketamine 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 Crossover Treatment Sequence 14 Phentermine 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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
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
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.
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
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