Narcotic AbusePhase 1NCT01595867
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
A Phase 1 study testing EMBEDA - morphine sulfate/ naltrexone hydrochloride and morphine sulfate CR crushed. in people with Narcotic Abuse and Opioid-related Disorders, run by Pfizer.
Trial summary
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcotic Abuse, Opioid-related Disorders, Analgesia
- What is being tested?
- EMBEDA - morphine sulfate/ naltrexone hydrochloride and morphine sulfate CR crushed.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 2011
- 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.
- Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
- Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.
Who cannot join
- Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
- Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
- Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
- Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
- History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
- History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
- Conditions
- Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
- Being tested
- Placebo, EMBEDA - morphine sulfate/ naltrexone hydrochloride, morphine sulfate CR crushed.
- Keywords
- abuse liability, abuse potential, morphine, intranasal administration, snorting, opioid abuse, pharmacodynamic, recreational drug use
- Medical subject headings
- Narcotic-Related Disorders, Opioid-Related Disorders, Agnosia, Chronic Pain, Recreational Drug Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Lactose (100 mg) placebo tablets crushed; single dose
EMBEDA - morphine sulfate/ naltrexone hydrochlorideDrug
EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
morphine sulfate CR crushed.Drug
Morphine sulfate controlled release 30 mg tablet crushed
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Placebo comparator | Placebo Receives: Drug: Placebo |
| Treatment B | Experimental | EMBEDA 30 mg crushed Receives: Drug: EMBEDA - morphine sulfate/ naltrexone hydrochloride |
| Treatment C | Active comparator | Morphine Sulfate Controlled Release 30 mg crushed Receives: Drug: morphine sulfate CR crushed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug Liking Visual Analog Scale maximum peak effect (Emax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale maximum peak effect (Emax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Secondary outcomes (122)
Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area time to maximum effect (TEmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale maximum peak effect (Emax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale maximum peak effect (Emax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale maximum peak effect (Emax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area time to maximum effect (TEmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale maximum peak effect (Emax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Nausea Visual Analog Scale Area time to maximum effect (TEmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale maximum peak effect (Emax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Sleepy Visual Analog Scale Area time to maximum effect (TEmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale maximum peak effect (Emax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Dizzy Visual Analog Scale Area time to maximum effect (TEmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter minimum peak effect (Emin)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter time to minimum peak effect (TEmin)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 4 hours (AUE0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 8 hours (AUE0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 12 hours (AUE0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Pupil Diameter Area under the effect curve to 24 hours (AUE0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Take Drug Again Visual Analog Scale maximum peak effect (Emax)
Measured: 12 and 24 hours post dose
Take Drug Again Visual Analog Scale mean (Emean)
Measured: 12 and 24 hours post dose
Overall Drug Liking Visual Analog Scale maximum peak effect (Emax)
Measured: 12 and 24 hours post dose
Overall Drug Liking Visual Analog Scale mean (Emean)
Measured: 12 and 24 hours post dose
Subject Rating Scale - Need to Blow Nose maximum peak effect (Emax)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Need to Blow Nose Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Need to Blow Nose Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge maximum peak effect (Emax)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Runny Nose/Nasal Discharge Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Burning maximum peak effect (Emax)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Burning Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Burning Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Facial Pain/Pressure maximum peak effect (Emax)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Facial Pain/Pressure Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Nasal Congestion maximum peak effect (Emax)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Nasal Congestion Area under the effect curve to 1 hour (AUE0-1h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Subject Rating Scale - Nasal Congestion Area under the effect curve to 2 hours (AUE0-2h)
Measured: pre dose and 0.5, 1, 1.5, and 2 hours post dose
Plasma morphine - Maximum observed plasma concentration (Cmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Time to maximum observed plasma concentration (Tmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Maximum observed plasma concentration (Cmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol - Time to maximum observed plasma concentration (Tmax
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma 6-ß-naltrexol- Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma morphine - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 1 hour (AUC0-1h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 12 hours (AUC0-12h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 24 hours (AUC0-24h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 4 hours (AUC0-4h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to 8 hours (AUC0-8h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Area under the plasma concentration time curve from time zero to infinity (AUC0-8), as applicable
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Maximum observed plasma concentration (Cmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone - Time to maximum observed plasma concentration (Tmax)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Plasma naltrexone- Area under the plasma concentration time curve from time zero to 2 hours (AUC0-2h)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 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 posted10 May 2012 (estimated)
- Study startAug 2010
- Primary completionJan 2011
- Study completionJan 2011
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 Narcotic AbuseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595867
- Sponsor's protocol ID
- ALO-01-10-4004
- Other IDs
- B4541005
- Status last verified
- Jun 2012
- First submitted
- 8 May 2012
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62. doi: 10.1155/2013/952082.
PubMed 23936895
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration
- ClinicalTrials.gov ID
- NCT01595867
- Acronym / sponsor ID
- ALO-01-10-4004
- Conditions
- Narcotic Abuse, Opioid-related Disorders, Analgesia, Chronic Pain
- Keywords
- abuse liability, abuse potential, morphine, intranasal administration, snorting, opioid abuse, pharmacodynamic, recreational drug use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 May 2012 (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 single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Placebo comparator | Drug: PlaceboPlacebo |
| Treatment B | Experimental | Drug: EMBEDA - morphine sulfate/ naltrexone hydrochlorideEMBEDA 30 mg crushed |
| Treatment C | Active comparator | Drug: morphine sulfate CR crushed.Morphine Sulfate Controlled Release 30 mg crushed |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects 18 to 55 years of age, inclusive.
- Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
- Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.
Key exclusion criteria (6 listed)
- Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
- Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
- Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
- Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
- History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
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 |
|---|---|---|
| PlaceboLactose (100 mg) placebo tablets crushed; single dose | Drug | Treatment A |
| EMBEDA - morphine sulfate/ naltrexone hydrochlorideEMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose | Drug | Treatment B |
| morphine sulfate CR crushed.Morphine sulfate controlled release 30 mg tablet crushed | Drug | Treatment C |
Primary outcome
Drug Liking Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
122 secondary outcomes
Drug Liking Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Drug Liking Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High VVisual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
High Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Any Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Good Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale maximum peak effect (Emax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 8 hours (AUE0-8h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 12 hours (AUE0-12h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area under the effect curve to 24 hours (AUE0-24h)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Bad Drug Effects Visual Analog Scale Area time to maximum effect (TEmax)
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale maximum peak effect (Emax)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 1 hour (AUE0-1h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 2 hours (AUE0-2h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose
Feel Sick Visual Analog Scale Area under the effect curve to 4 hours (AUE0-4h)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 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 8 Jun 2012.
- Derived from this study: PubMed 23936895Setnik B, Goli V, Levy-Cooperman N, Mills C, Shram M, Smith I. Assessing the subjective and physiological effects of intranasally administered crushed extended-release morphine formulations with and without a sequestered naltrexone core in recreational opioid users. Pain Res Manag. 2013 Jul-Aug;18(4):e55-62. doi: 10.1155/2013/952082.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMBEDA - morphine sulfate/ naltrexone hydrochloride and morphine sulfate CR crushed. in people with Narcotic Abuse and Opioid-related Disorders, run by Pfizer.
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 3 inclusion and 6 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 8 Jun 2012. 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. 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?
Drug Liking Visual Analog Scale maximum peak effect (Emax) (time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8,12, and 24 hours post-dose). The study lists 4 primary outcomes in all. 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 NCT01595867, 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 8 Jun 2012.