Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intr… (NCT02682225) | Clinical Trial Compass
CompletedPhase 1
Crossover Study to Evaluate the Abuse Potential of Intranasal Esketamine Compared to Racemic Intravenous Ketamine in Nondependent, Recreational Drug Users
United States55 participantsStarted 2016-03-25
Plain-language summary
The primary objective of this study is to evaluate the abuse potential of intranasal esketamine (112 milligram and 84 mg) compared to racemic intravenous ketamine (0.5 mg/kg) in nondependent, recreational polydrug users of perception-altering drugs.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Participants with body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2) (inclusive), and body weight not less than 50 kg
* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study, including the pharmacogenomic research component of the study
* Be a current, recreational, nondependent, polydrug user defined as nonmedical use with at least 2 types of perception-altering drugs of abuse (example, lysergic acid diethylamide, cannabinoids, ketamine, ecstasy/3,4-methylenedioxy-methamphetamine, phencyclidine, psilocybin, and ring-substituted amphetamines with perception altering effects) and at least 10 total lifetime occasions of use with perception-altering drugs of abuse and who like their effects
* Report having used ketamine at least once in a lifetime without moderate or severe adverse effects
* Report having used a perception-altering drug (example, lysergic acid diethylamide, cannabinoids, ketamine, ecstasy/3,4-methylenedioxy-methamphetamine, phencyclidine, psilocybin, and ring substituted amphetamines with perception altering effects) at least once within 3 months prior to the screening phase without moderate or severe adverse effects
Exclusion Criteria:
* Participant with a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic dise…
What they're measuring
1
Change From Baseline in abuse potential based on Visual Analog Scale
Timeframe: up to Day 2 Period 4 in Treatment Phase