Abuse Potential StudyPhase 1NCT01987739
Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users
A Phase 1 study testing 200 mg almorexant, 400 mg almorexant and 1000 mg almorexant in people with Abuse Potential Study, run by Midnight Pharma, LLC.
Trial summary
This was a six-way crossover study with six single-dose treatment sessions. The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Abuse Potential Study
- What is being tested?
- 200 mg almorexant, 400 mg almorexant and 1000 mg almorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Feb 2010
- 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
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Recreational drug use with a history of CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties (e.g., benzodiazepines, barbiturates, gammahydroxybutyric acid (GHB), zopiclone, zolpidem, cannabis, etc.), and at least one instance of non-medical use in the past year.
- Body mass index (BMI) within the range of 18 to 32 kg/m^2, inclusive, and a minimum weight of 50 kg.
- Female subjects of childbearing potential must have been practicing strict sexual abstinence or using a medically acceptable and reliable form of birth control with a failure rate of < 1% per year from at least 1 month prior to Screening (at least 3 months for oral contraceptives) and for at least 1 month after the last study drug administration. Accepted methods of contraception included implants, injectables, combined oral hormonal contraceptives, some intrauterine devices, sexual abstinence, tubal ligation, or vasectomized partner.
- Female subjects of non-childbearing potential must have been amenorrheic for at least 1 year following natural menopause or had a hysterectomy and/or bilateral oophorectomy (as determined by subject medical history).
- Female subjects must have had a negative pregnancy test at Screening and at each admission.
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- Must have passed Qualification Visit eligibility criteria.
- Must have been able to speak, read, and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow completion of all study assessments.
- Willing and able to abide by all study requirements and restrictions.
- Give voluntary written informed consent to participate in the study.
Who cannot join
- Received an investigational drug in a clinical trial within 30 days prior to the Screening Visit.
- Drug or alcohol dependence (except nicotine or caffeine) in the past 2 years as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), including subjects who had ever been in a drug rehabilitation program (other than treatment for smoking cessation).
- Unwillingness or inability to abstain from recreational drug use as required for the study.
- Positive urine drug screen at admission to Qualification or any Treatment Visit greater than the established threshold value, except for cannabinoids (THC; due to slow release from adipose tissue). If THC was positive, inclusion was at the discretion of the investigator or designee. Subjects with a positive urine drug screen were rescheduled up to 2-times at the investigator's/designee's discretion.
- Positive breath alcohol test at Screening or at any admission.
- Clinically significant abnormalities on physical examination, medical history, 12-lead electrocardiogram (ECG), vital signs, or laboratory tests, including a history or presence of psychiatric, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition, which in the opinion of the investigator would have jeopardized the safety of the subject or the validity of the study results.
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- Previous history of fainting, collapses, syncope, orthostatic hypotension, or vasovagal reactions.
- Use of non-prescription medication, prescription medication, or natural health products (except vitamin or mineral supplements, acceptable forms of birth control, and hormone replacement) within 7 days prior to first drug administration in the Qualification Visit and throughout the study. Up to 1 g per day of acetaminophen was allowed at the discretion of the investigator. Concomitant medication known to inhibit or induce the cytochrome P3A4 isoenzyme was not allowed. Treatment with drugs metabolized by the cytochrome P2D6 isoenzyme was not allowed.
- History of allergy or hypersensitivity to study drugs, related drugs (e.g., benzodiazepines or gamma-aminobutyric acid related drugs) or excipients (including lactose).
About this study
Official title: A Single Center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Central Nervous System (CNS) Depressant Drug Users
This was a six-way crossover study with six single-dose treatment sessions. The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem
Read the detailed description
This was a prospective, randomized, double-blind, double-dummy, balanced, placebo and active-controlled, six-way crossover Phase 1 study with six single-dose treatment sessions. The profile of acute effects on pharmacodynamic abuse potential measures of different almorexant doses was compared with that of placebo and two doses of zolpidem.
- Conditions
- Abuse Potential Study
- Being tested
- 200 mg almorexant, 400 mg almorexant, 1000 mg almorexant, 20 mg zolpidem, 40 mg zolpidem
- Keywords
- Almorexant, Zolpidem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg almorexantDrug
400 mg almorexantDrug
1000 mg almorexantDrug
20 mg zolpidemDrug
40 mg zolpidemDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Subjects were randomized to receive single, oral doses of study medication in the sequence ABFCED, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. Receives: Drug: 200 mg almorexant; Drug: 400 mg almorexant; Drug: 1000 mg almorexant; Drug: 20 mg zolpidem; Drug: 40 mg zolpidem; Drug: placebo |
| Arm 2 | Experimental | Subjects were randomized to receive single, oral doses of study medication in the sequence BCADFE, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. Receives: Drug: 200 mg almorexant; Drug: 400 mg almorexant; Drug: 1000 mg almorexant; Drug: 20 mg zolpidem; Drug: 40 mg zolpidem; Drug: placebo |
| Arm 3 | Experimental | Subjects were randomized to receive single, oral doses of study medication in the sequence CDBEAF, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. Receives: Drug: 200 mg almorexant; Drug: 400 mg almorexant; Drug: 1000 mg almorexant; Drug: 20 mg zolpidem; Drug: 40 mg zolpidem; Drug: placebo |
| Arm 4 | Experimental | Subjects were randomized to receive single, oral doses of study medication in the sequence DECFBA, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. Receives: Drug: 200 mg almorexant; Drug: 400 mg almorexant; Drug: 1000 mg almorexant; Drug: 20 mg zolpidem; Drug: 40 mg zolpidem; Drug: placebo |
| Arm 5 | Experimental | Subjects were randomized to receive single, oral doses of study medication in the sequence EFDACB, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. Receives: Drug: 200 mg almorexant; Drug: 400 mg almorexant; Drug: 1000 mg almorexant; Drug: 20 mg zolpidem; Drug: 40 mg zolpidem; Drug: placebo |
| Arm 6 | Experimental | Subjects were randomized to receive single, oral doses of study medication in the sequence FAEBDC, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. Receives: Drug: 200 mg almorexant; Drug: 400 mg almorexant; Drug: 1000 mg almorexant; Drug: 20 mg zolpidem; Drug: 40 mg zolpidem; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum effect (Emax) over 24 h post-dose for "At the moment" Drug Liking Visual Analogue Scale (VAS) score during each Treatment Visit
Emax was determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented a 'Strong disliking' and a score of '100' represented a 'Strong liking'.
Measured: 24 hours
Secondary outcomes (16)
Minimum Effect (Emin) and Time-weighted mean effect (TWMean) over 24 h post-dose for "At the moment" Drug Liking VAS score during each Treatment Visit
Emin and TWMean were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented a 'Strong disliking' and a score of '100' represented a 'Strong liking'.
Measured: 24 hours
Overall Drug Liking VAS score (Emax, Emin, and arithmetic mean effect of 8 h and 24 h post-dose assessments during each Treatment Visit)
Overall drug liking was determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented a 'Strong disliking' and a score of '100' represented a 'Strong liking'.
Measured: 24 hours
Good/Bad Drug Effects VAS score (Emax, Emin, and TWMean over 24 h post-dose during each Treatment Visit)
Good/Bad Drug Effects were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'I can feel bad effects' and a score of '100' represented 'I can feel good effects'.
Measured: 24 hours
Take Drug Again VAS score (Emax and arithmetic mean of 8 h and 24 h post-dose assessments during each Treatment Visit)
Take drug again scores were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'Definitely not' and a score of '100' represented 'Definitely so'.
Measured: 24 hours
Subjective Drug Value (SDV) (Emax and arithmetic mean of 8 h and 24 h post-dose assessment during each Treatment Visit)
The SDV measure involved a series of independent, theoretical forced choices between the drug administered and different monetary values. Subjects were asked to choose between receiving another dose of the same drug to take home or an envelope containing a specified amount of money. However, they did not actually receive either the drug or the money offered in the choices. The monetary value of the drug or the envelope ranged from $0.25 to $50.00.
Measured: 24 hours
Feeling High VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Feeling high scores were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'Definitely not' and a score of '100' represented 'Definitely so'.
Measured: 24 hours
Good Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Feeling good drug effect scores were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'Definitely not' and a score of '100' represented 'Definitely so'.
Measured: 24 hours
Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG) scale (Emax and TWMean over 24 h postdose during each Treatment Visit)
Subjects responded by selecting "False" or "True" with a mouse. One point was given for each response that agreed with the scoring direction on the scale (i.e., true items received a score of 1 if the answer was "True", false items received a score of 1 if the answer was "False"). No points were given when the answer was opposite to the scoring direction. The questions and scoring were part of the 49-item ARCI scale.
Measured: 24 hours
Bad Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Feeling bad drug effect scores were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'Definitely not' and a score of '100' represented 'Definitely so'.
Measured: 24 hours
ARCI Lysergic acid diethylamide (LSD) scale (Emax and TWMean over 24 h post-dose during each Treatment Visit
Subjects responded by selecting "False" or "True" with a mouse. One point was given for each response that agreed with the scoring direction on the scale (i.e., true items received a score of 1 if the answer was "True", false items received a score of 1 if the answer was "False"). No points were given when the answer was opposite to the scoring direction. The questions and scoring were part of the 49-item ARCI scale.
Measured: 24 hours
ARCI Pentobarbital Chlorpromazine Alcohol Group (PCAG) scale (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Subjects responded by selecting "False" or "True" with a mouse. One point was given for each response that agreed with the scoring direction on the scale (i.e., true items received a score of 1 if the answer was "True", false items received a score of 1 if the answer was "False"). No points were given when the answer was opposite to the scoring direction. The questions and scoring were part of the 49-item ARCI scale.
Measured: 24 hours
Alertness/Drowsiness VAS score (Emin [drowsiness] and TWMean over 24 h post-dose during each Treatment Visit)
Alertness/drowsiness scores were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'Very drowsy' and a score of '100' represented 'Very alert'
Measured: 24 hours
Bowdle VAS scores (Emax and TWMean over 24 h post-dose during each Treatment Visit)
The Bowdle VAS [Bowdle 1998] consists of 13 items for which the subjects were asked to rate their current feelings. Each VAS was scored from 0 to 100, with 0 reflecting "not at all" and 100 reflecting "extremely". Lower individual and overall scores indicated fewer psychedelic effects. The scale was adapted for computer presentation and took approximately 3 minutes to complete.
Measured: 24 hours
Any Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Feeling any drug effects scores were determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented 'Definitely not' and a score of '100' represented 'Definitely so'.
Measured: 24 hours
Drug Familiarity VAS score (Hour 12 during each Treatment Visit)
Drug familiarity score was determined by asking a general question "How familiar was the effect of the drug you most recently received?" Subjects scored familiarity on a VAS scale from 0-100 where 0 was 'Very unfamiliar' and 100 was 'Very familiar'.
Measured: 12 hours
Drug Similarity VAS score (Hour 12 during each Treatment Visit)
Drug similarity scores were determined by asking 'How similar is the drug you most recently received to [each of a specific drug from a customized list of drugs to which the subject was familiar]?". Subjects scored similarity for each drug on a VAS scale from 0-100 where 0 was 'Not at all similar' and 100 was 'Very similar'.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startSep 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abuse Potential StudyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midnight Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward M Sellers, MD, PhD, Principal investigator, Kendle Early Stage - Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987739
- Sponsor's protocol ID
- AC-057-116
- Status last verified
- Feb 2016
- First submitted
- 13 Nov 2013
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Central Nervous System (CNS) Depressant Drug Users
- ClinicalTrials.gov ID
- NCT01987739
- Acronym / sponsor ID
- AC-057-116
- Conditions
- Abuse Potential Study
- Keywords
- Almorexant, Zolpidem
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Midnight Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Nov 2013 (estimated)
- 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 was a six-way crossover study with six single-dose treatment sessions. The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem
Detailed description
This was a prospective, randomized, double-blind, double-dummy, balanced, placebo and active-controlled, six-way crossover Phase 1 study with six single-dose treatment sessions. The profile of acute effects on pharmacodynamic abuse potential measures of different almorexant doses was compared with that of placebo and two doses of zolpidem.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: 200 mg almorexant, Drug: 400 mg almorexant, Drug: 1000 mg almorexant, Drug: 20 mg zolpidem, Drug: 40 mg zolpidem, Drug: placeboSubjects were randomized to receive single, oral doses of study medication in the sequence ABFCED, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. |
| Arm 2 | Experimental | Drug: 200 mg almorexant, Drug: 400 mg almorexant, Drug: 1000 mg almorexant, Drug: 20 mg zolpidem, Drug: 40 mg zolpidem, Drug: placeboSubjects were randomized to receive single, oral doses of study medication in the sequence BCADFE, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. |
| Arm 3 | Experimental | Drug: 200 mg almorexant, Drug: 400 mg almorexant, Drug: 1000 mg almorexant, Drug: 20 mg zolpidem, Drug: 40 mg zolpidem, Drug: placeboSubjects were randomized to receive single, oral doses of study medication in the sequence CDBEAF, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. |
| Arm 4 | Experimental | Drug: 200 mg almorexant, Drug: 400 mg almorexant, Drug: 1000 mg almorexant, Drug: 20 mg zolpidem, Drug: 40 mg zolpidem, Drug: placeboSubjects were randomized to receive single, oral doses of study medication in the sequence DECFBA, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. |
| Arm 5 | Experimental | Drug: 200 mg almorexant, Drug: 400 mg almorexant, Drug: 1000 mg almorexant, Drug: 20 mg zolpidem, Drug: 40 mg zolpidem, Drug: placeboSubjects were randomized to receive single, oral doses of study medication in the sequence EFDACB, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. |
| Arm 6 | Experimental | Drug: 200 mg almorexant, Drug: 400 mg almorexant, Drug: 1000 mg almorexant, Drug: 20 mg zolpidem, Drug: 40 mg zolpidem, Drug: placeboSubjects were randomized to receive single, oral doses of study medication in the sequence FAEBDC, where, Treatment A was: 200 mg almorexant; Treatment B was 400 mg almorexant; Treatment C was 1000 mg almorexant; Treatment D was 20 mg zolpidem; Treatment E was 40 mg zolpidem; and Treatment F was placebo. The duration of each Treatment Visit was 1 day/2 nights. Study drug was administered on Day 1 of each Treatment Visit. Each treatment was separated by a washout period of at least 10 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Recreational drug use with a history of CNS depressant use, defined as at least 10 lifetime occasions of non-medical use of drugs with depressant/sedative properties (e.g., benzodiazepines, barbiturates, gammahydroxybutyric acid (GHB), zopiclone, zolpidem, cannabis, etc.), and at least one instance of non-medical use in the past year.
- Body mass index (BMI) within the range of 18 to 32 kg/m^2, inclusive, and a minimum weight of 50 kg.
- Female subjects of childbearing potential must have been practicing strict sexual abstinence or using a medically acceptable and reliable form of birth control with a failure rate of < 1% per year from at least 1 month prior to Screening (at least 3 months for oral contraceptives) and for at least 1 month after the last study drug administration. Accepted methods of contraception included implants, injectables, combined oral hormonal contraceptives, some intrauterine devices, sexual abstinence, tubal ligation, or vasectomized partner.
- Female subjects of non-childbearing potential must have been amenorrheic for at least 1 year following natural menopause or had a hysterectomy and/or bilateral oophorectomy (as determined by subject medical history).
Key exclusion criteria (9 listed)
- Received an investigational drug in a clinical trial within 30 days prior to the Screening Visit.
- Drug or alcohol dependence (except nicotine or caffeine) in the past 2 years as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), including subjects who had ever been in a drug rehabilitation program (other than treatment for smoking cessation).
- Unwillingness or inability to abstain from recreational drug use as required for the study.
- Positive urine drug screen at admission to Qualification or any Treatment Visit greater than the established threshold value, except for cannabinoids (THC; due to slow release from adipose tissue). If THC was positive, inclusion was at the discretion of the investigator or designee. Subjects with a positive urine drug screen were rescheduled up to 2-times at the investigator's/designee's discretion.
- Positive breath alcohol test at Screening or at any admission.
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 |
|---|---|---|
| 200 mg almorexant | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| 400 mg almorexant | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| 1000 mg almorexant | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| 20 mg zolpidem | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| 40 mg zolpidem | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
| placebo | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6 |
Primary outcome
Maximum effect (Emax) over 24 h post-dose for "At the moment" Drug Liking Visual Analogue Scale (VAS) score during each Treatment Visit
Time frame: 24 hours
Emax was determined on a Drug Liking VAS which assessed positive and negative drug effects (Griffiths 2003, Milovan 2009, Schoedel 2008). VAS items were displayed on two screen images. Using a mouse, the subject positioned the cursor over the small vertical box ("slider") and clicked on it to move it left or right on a scale of 0-100. To register the response, the subject then pressed the "OK" button that appeared below the horizontal line. A score of '0' represented a 'Strong disliking' and a score of '100' represented a 'Strong liking'.
16 secondary outcomes
Minimum Effect (Emin) and Time-weighted mean effect (TWMean) over 24 h post-dose for "At the moment" Drug Liking VAS score during each Treatment Visit
Time frame: 24 hours
Overall Drug Liking VAS score (Emax, Emin, and arithmetic mean effect of 8 h and 24 h post-dose assessments during each Treatment Visit)
Time frame: 24 hours
Good/Bad Drug Effects VAS score (Emax, Emin, and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Take Drug Again VAS score (Emax and arithmetic mean of 8 h and 24 h post-dose assessments during each Treatment Visit)
Time frame: 24 hours
Subjective Drug Value (SDV) (Emax and arithmetic mean of 8 h and 24 h post-dose assessment during each Treatment Visit)
Time frame: 24 hours
Feeling High VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Good Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG) scale (Emax and TWMean over 24 h postdose during each Treatment Visit)
Time frame: 24 hours
Bad Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
ARCI Lysergic acid diethylamide (LSD) scale (Emax and TWMean over 24 h post-dose during each Treatment Visit
Time frame: 24 hours
ARCI Pentobarbital Chlorpromazine Alcohol Group (PCAG) scale (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Alertness/Drowsiness VAS score (Emin [drowsiness] and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Bowdle VAS scores (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Any Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)
Time frame: 24 hours
Drug Familiarity VAS score (Hour 12 during each Treatment Visit)
Time frame: 12 hours
Drug Similarity VAS score (Hour 12 during each Treatment Visit)
Time frame: 12 hours
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 12 Feb 2016.
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.
Edward M Sellers, MD, PhD principal investigator
Kendle Early Stage - Toronto
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 200 mg almorexant, 400 mg almorexant and 1000 mg almorexant in people with Abuse Potential Study, run by Midnight Pharma, LLC.
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 10 inclusion and 9 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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) over 24 h post-dose for "At the moment" Drug Liking Visual Analogue Scale (VAS) score during each Treatment Visit (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.