Healthy Recreational Drug UsersPhase 1NCT03657355
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
A Phase 1 study testing ACT-541468, Suvorexant and Zolpidem in people with Healthy Recreational Drug Users, run by Idorsia Pharmaceuticals Ltd. at 2 sites in 2 countries.
Trial summary
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Recreational Drug Users
- What is being tested?
- ACT-541468, Suvorexant and Zolpidem
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Sep 2018to 8 Aug 2019
- 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
- Signed informed consent prior to any study-mandated procedure
- Male or female healthy subjects, 18-55 years of age (inclusive) at Screening
- Body mass index of 18.0-33.0 kg/m2 (inclusive) at Screening and a minimum weight of 50.0 kg at Screening
- Current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before Screening
- Women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner
- Women of non-childbearing potential
- Male subjects are required to use a medically acceptable method of contraception throughout the entire study period and for at least 90 days after last study drug administration
Who cannot join
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s)
- Positive HIV or hepatitis B/C test at Screening
- Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration
- Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy
- Substance or alcohol dependence within 2 years prior to Screening or prior participation in a substance or alcohol dependence rehabilitation program
- Subjects who have a positive urine drug screen at admittance to the qualification or core phase
Show all 16Show fewer
- Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome (RLS), nightmare disorder, non-rapid eye movement (REM), sleep arousal disorders, REM sleep behavior disorder, circadian rhythm sleep-wake disorders, or narcolepsy
- Any of the following SLEEP-50 Questionnaire scores at Screening:
- ≥ 15 on Apnea subscale;
- ≥ 7 on Narcolepsy subscale;
- ≥ 7 on RLS or Periodic limb movement disorder subscale;
- ≥ 8 on Circadian Rhythm subscale;
- ≥ 7 on Sleepwalking subscale;
- ≥ 3 on Item 32 and ≥ 9 on Items 33 to 35 (i.e., on nightmare subscale);
- ≥ 15 on Impact subscale.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.)
Overland Park, Kansas, 66212
About this study
Official title: Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 6-way Cross-over Study to Evaluate the Abuse Potential of Single, Oral Doses of ACT-541468 in Healthy Recreational Drug Users
This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
- Conditions
- Healthy Recreational Drug Users
- Being tested
- ACT-541468, Suvorexant, Zolpidem, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-541468Drug
ACT-541468 will be administered as 50 mg tablets for oral use.
SuvorexantDrug
Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.
ZolpidemDrug
Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.
PlaceboDrug
Matching-placebo will be used.
| Study group | Role | What they receive |
|---|---|---|
| 50 mg ACT-541468 | Experimental | ACT-541468 will be administered as tablets for oral use. Receives: Drug: ACT-541468 |
| 100 mg ACT-541468 | Experimental | ACT-541468 will be administered as tablets for oral use. Receives: Drug: ACT-541468 |
| 150 mg ACT-541468 | Experimental | ACT-541468 will be administered as tablets for oral use. Receives: Drug: ACT-541468 |
| 150 mg suvorexant | Active comparator | Suvorexant will be administered as tablets for oral use. Receives: Drug: Suvorexant |
| 30 mg zolpidem | Active comparator | Zolpidem will be administered as tablets for oral use. Receives: Drug: Zolpidem |
| Placebo | Placebo comparator | Placebo will be administered as tablets for oral use. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period
VAS = visual analogue scale
Measured: Duration: for up to 24 hours post-dose
Secondary outcomes (14)
Drug Liking VAS (bipolar)
VAS = visual analogue scale
Measured: Duration: for up to 24 hours post-dose
Overall Drug Liking VAS (bipolar)
VAS = visual analogue scale
Measured: Duration: for up to 12 hours post-dose
Take Drug Again VAS (bipolar)
Measured: Duration: for up to 12 hours post-dose
Good Effects VAS (unipolar)
Measured: Duration: for up to 24 hours post-dose
Drug Similarity VAS
VAS = visual analogue scale
Measured: Duration: for up to 1 hour post-dose
Bad Effects VAS (unipolar)
VAS = visual analogue scale
Measured: Duration: for up to 24 hours post-dose
Alertness/Drowsiness VAS (bipolar)
VAS = visual analogue scale
Measured: Duration: for up to 24 hours post-dose
Any Effects VAS (unipolar)
VAS = visual analogue scale
Measured: Duration: for up to 24 hours post-dose
Feeling High VAS (unipolar)
VAS = visual analogue scale
Measured: Duration: for up to 24 hours post-dose
Bowdle VAS Internal and External Perceptions
Measured: Duration: for up to 24 hours post-dose
Observer's Assessment of Alertness/Sedation composite and sum scores
Measured: Duration: for up to 24 hours post-dose
Reaction time task score
Measured: Duration: for up to 8 hours post-dose
Rapid visual information processing score
Measured: Duration: for up to 8 hours post-dose
Paired Associates Learning score
Measured: Duration: for up to 8 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start7 Sep 2018
- Primary completion8 Aug 2019
- Study completion8 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Recreational Drug UsersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657355
- Sponsor's protocol ID
- ID-078-107
- Status last verified
- Sep 2019
- First submitted
- 31 Aug 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ufer M, Kelsh D, Schoedel KA, Dingemanse J. Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem. Sleep. 2022 Mar 14;45(3):zsab224. doi: 10.1093/sleep/zsab224.
PubMed 34480579
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 6-way Cross-over Study to Evaluate the Abuse Potential of Single, Oral Doses of ACT-541468 in Healthy Recreational Drug Users
- ClinicalTrials.gov ID
- NCT03657355
- Acronym / sponsor ID
- ID-078-107
- Conditions
- Healthy Recreational Drug Users
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Aug 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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 placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over study
| Arm | Type | Receives |
|---|---|---|
| 50 mg ACT-541468 | Experimental | Drug: ACT-541468ACT-541468 will be administered as tablets for oral use. |
| 100 mg ACT-541468 | Experimental | Drug: ACT-541468ACT-541468 will be administered as tablets for oral use. |
| 150 mg ACT-541468 | Experimental | Drug: ACT-541468ACT-541468 will be administered as tablets for oral use. |
| 150 mg suvorexant | Active comparator | Drug: SuvorexantSuvorexant will be administered as tablets for oral use. |
| 30 mg zolpidem | Active comparator | Drug: ZolpidemZolpidem will be administered as tablets for oral use. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered as tablets for oral use. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent prior to any study-mandated procedure
- Male or female healthy subjects, 18-55 years of age (inclusive) at Screening
- Body mass index of 18.0-33.0 kg/m2 (inclusive) at Screening and a minimum weight of 50.0 kg at Screening
- Current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before Screening
- Women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner
Key exclusion criteria (16 listed)
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s)
- Positive HIV or hepatitis B/C test at Screening
- Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration
- Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy
- Substance or alcohol dependence within 2 years prior to Screening or prior participation in a substance or alcohol dependence rehabilitation program
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 |
|---|---|---|
| ACT-541468ACT-541468 will be administered as 50 mg tablets for oral use. | Drug | 100 mg ACT-541468, 150 mg ACT-541468, 50 mg ACT-541468 |
| SuvorexantSuvorexant will be administered as 15 mg over-encapsulated tablets for oral use. | Drug | 150 mg suvorexant |
| ZolpidemZolpidem will be administered as 10 mg over-encapsulated tablets for oral use. | Drug | 30 mg zolpidem |
| PlaceboMatching-placebo will be used. | Drug | Placebo |
Primary outcome
Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period
Time frame: Duration: for up to 24 hours post-dose
VAS = visual analogue scale
14 secondary outcomes
Drug Liking VAS (bipolar)
Time frame: Duration: for up to 24 hours post-dose
Overall Drug Liking VAS (bipolar)
Time frame: Duration: for up to 12 hours post-dose
Take Drug Again VAS (bipolar)
Time frame: Duration: for up to 12 hours post-dose
Good Effects VAS (unipolar)
Time frame: Duration: for up to 24 hours post-dose
Drug Similarity VAS
Time frame: Duration: for up to 1 hour post-dose
Bad Effects VAS (unipolar)
Time frame: Duration: for up to 24 hours post-dose
Alertness/Drowsiness VAS (bipolar)
Time frame: Duration: for up to 24 hours post-dose
Any Effects VAS (unipolar)
Time frame: Duration: for up to 24 hours post-dose
Feeling High VAS (unipolar)
Time frame: Duration: for up to 24 hours post-dose
Bowdle VAS Internal and External Perceptions
Time frame: Duration: for up to 24 hours post-dose
Observer's Assessment of Alertness/Sedation composite and sum scores
Time frame: Duration: for up to 24 hours post-dose
Reaction time task score
Time frame: Duration: for up to 8 hours post-dose
Rapid visual information processing score
Time frame: Duration: for up to 8 hours post-dose
Paired Associates Learning score
Time frame: Duration: for up to 8 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 34480579Ufer M, Kelsh D, Schoedel KA, Dingemanse J. Abuse potential assessment of the new dual orexin receptor antagonist daridorexant in recreational sedative drug users as compared to suvorexant and zolpidem. Sleep. 2022 Mar 14;45(3):zsab224. doi: 10.1093/sleep/zsab224.
- Individual participant dataSharing planned: No
Related trials for Healthy Recreational Drug Users
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.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-541468, Suvorexant and Zolpidem in people with Healthy Recreational Drug Users, run by Idorsia Pharmaceuticals Ltd. at 2 sites in 2 countries.
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 7 inclusion and 16 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: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period (time frame: Duration: for up to 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 NCT03657355, which also lists 1 linked publication.
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 19 Sep 2019.