Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Dete… (NCT04647903) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)
United States55 participantsStarted 2020-10-05
Plain-language summary
This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male or female volunteers, 18 to 55 years of age inclusive
* Recreational drug abuse experience (\>/= 10 times lifetime abuse of a CNS stimulant, \>/= 1 abuse of CNS stimulant in the previous 3 months)
* Prior intranasal recreational drug abuse experience
* Body mass index (BMI) 18 to 33 kg/m2 inclusive
Exclusion Criteria:
* History of any significant disease or disorder
* History or current diagnosis of substance dependence (excluding caffeine and nicotine)
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women
* Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
* Confirmed positive drug screening
* Positive alcohol breath test at screening / any Day -1
* Heavy smoker (\> 20 cigarettes, \> 8 pipefuls or \> 8 cigars per day)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.