Chronic PainPhase 4NCT01100437

Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients

A Phase 4 study testing EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush and EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole in people with Chronic Pain, run by Pfizer at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Chronic Pain
What is being tested?: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush and EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Mar 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Chronic moderate to severe non-cancer pain that has been treated with opioid analgesics for at least three months (with stabilized pain control and stabilized dose for 28 days prior to enrollment).
Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.
Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following naloxone administration during the Naloxone Challenge.
If female and able to become pregnant, must use an approved method of birth control.
Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12 lead electrocardiogram (ECG).

Who cannot join

Female who is pregnant or breastfeeding.
Patient has a known allergy or history of significant adverse reaction to morphine, other opioids, naltrexone, acetaminophen, or related compounds.
Patient is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within the 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
History of, or ongoing, alcohol or drug abuse.
Patient has made a donation of blood or has had a significant blood loss within 30 days prior to screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

Lifetree Clinical Research
Salt Lake City, Utah, 84106

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Double-Blind, Two-Way Crossover Study to Evaluate Whether a Single-Dose Administration of Crushed and Whole EMBEDA Induces Clinical Opiate Withdrawal Signs and Symptoms in Opioid-Dependent Patients With Chronic, Non-Cancer Pain Who Are Stabilized on EMBEDA¿

This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.

Read the detailed description

The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.

Conditions: Chronic Pain
Being tested: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush, EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Keywords: opioid, morphine, naltrexone, withdrawal signs, withdrawal symptoms
Medical subject headings: Chronic Pain, Substance Withdrawal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crushDrug
Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) wholeDrug
EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution

Study groups in NCT01100437
Study group	Role	What they receive
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush	Experimental	EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally at each patient's stable dose, given either once daily or twice daily. Receives: Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole	Experimental	EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily Receives: Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase
COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)

Secondary outcomes (10)

Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases
Average pain scores in the previous 24 hours using an 11 point NPRS ranging from no pain (0) to worst pain (10).
Measured: Baseline up to Day 63
Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase
Average Tmax for Morphine, Naltrexone and 6-β-Naltrexol
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase
Average Cmax for Morphine, Naltrexone and 6-β-Naltrexol
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase
Average Cmin for Morphine, Naltrexone and 6-β-Naltrexol
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Apparent Oral Clearance (CL/F) During the Treatment Phase
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Volume of Distribution (Vd/F)During the Treatment Phase
Average Vd/F for Morphine, Naltrexone and 6-β-Naltrexol
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Plasma Decay Half-Life (t1/2) During the Treatment Phase
Average plasma decay half-life of morphine, naltrexone and 6-β-Naltrexol. Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase
Average AUC0-τ for Morphine, Naltrexone and 6-β-Naltrexol reported. τ=24 hours
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase
Average AUC0-last for Morphine, Naltrexone and 6-β-Naltrexol. Area under the plasma concentration time-curve from time zero to the last measured concentration.
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). Average AUC 0-∞ for Morphine, Naltrexone and 6-β-Naltrexol reported.
Measured: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Mar 2011

First posted9 Apr 2010 (estimated)
Study startApr 2010
Primary completionMar 2011
Study completionMar 2011

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies 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 4
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01100437
Sponsor's protocol ID: ALO-01-09-111
Other IDs: B4541002
Status last verified: Nov 2011
First submitted: 7 Apr 2010
Last updated: 13 Jul 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Setnik B, Roland CL, Goli V, Sommerville K, Webster L. A clinical trial to determine if corelease of morphine and naltrexone from crushed extended-release capsules induces withdrawal in opioid-dependent patients: a descriptive analysis of six patients. J Opioid Manag. 2013 Mar-Apr;9(2):139-50. doi: 10.5055/jom.2013.0155.
PubMed 23709323

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Double-Blind, Two-Way Crossover Study to Evaluate Whether a Single-Dose Administration of Crushed and Whole EMBEDA Induces Clinical Opiate Withdrawal Signs and Symptoms in Opioid-Dependent Patients With Chronic, Non-Cancer Pain Who Are Stabilized on EMBEDA¿
ClinicalTrials.gov ID: NCT01100437
Acronym / sponsor ID: ALO-01-09-111
Conditions: Chronic Pain
Keywords: opioid, morphine, naltrexone, withdrawal signs, withdrawal symptoms
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 14 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 9 Apr 2010 (estimated)
Results: Posted 28 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.

Detailed description

The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush	Experimental	Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crushEMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally at each patient's stable dose, given either once daily or twice daily.
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole	Experimental	Drug: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) wholeEMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Chronic moderate to severe non-cancer pain that has been treated with opioid analgesics for at least three months (with stabilized pain control and stabilized dose for 28 days prior to enrollment).
Receiving an opioid dose equivalent to 20 mg - 120 mg morphine once or twice daily.
Patient displays signs and symptoms of withdrawal (i.e., COWS score ≥5) following naloxone administration during the Naloxone Challenge.
If female and able to become pregnant, must use an approved method of birth control.
Excluding the chronic moderate to severe non-cancer pain, the patient is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, laboratory profile, and 12 lead electrocardiogram (ECG).

Key exclusion criteria (5 listed)

Female who is pregnant or breastfeeding.
Patient has a known allergy or history of significant adverse reaction to morphine, other opioids, naltrexone, acetaminophen, or related compounds.
Patient is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within the 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
History of, or ongoing, alcohol or drug abuse.
Patient has made a donation of blood or has had a significant blood loss within 30 days prior to screening.

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
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crushPlacebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily	Drug	EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush
EMBEDA™ (morphine sulfate/naltrexone hydrochloride) wholeEMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution	Drug	EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole

Primary outcome

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)
COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).

10 secondary outcomes

Average Numeric Pain Rating Scale (NPRS) in Titration/Stabilization and Maintenance Phases
Time frame: Baseline up to Day 63
Time to Reach Maximum Observed Plasma Concentration (Tmax) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Maximum Observed Plasma Concentration (Cmax) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Minimum Observed Plasma Concentration (Cmin) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Apparent Oral Clearance (CL/F) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Volume of Distribution (Vd/F)During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Plasma Decay Half-Life (t1/2) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-τ) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Area Under the Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] During the Treatment Phase
Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, and 24 hr post-dose

Results and safety

Results posted to the registry on 28 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EMBEDA Capsule Then EMBEDA Solution	4	4
EMBEDA Solution Then EMBEDA Capsule	2	2
EMBEDA Capsule	8	8

Primary outcome: Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase

Time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA). Number. Unit: participants

Measure	EMBEDA Whole Capsules n = 6	EMBEDA Crushed in Solution n = 6
Value	1	3

Population analysed: Intent-to-treat population (ITT): all randomized participants who received at least one dose of double-blind treatment in the Treatment Phase and had at least one post-dose pharmacodynamic assessment completed in the Treatment Phase.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study procedure related adverse events (AEs) were collected from the time of written Informed Consent and all other AEs from the time of the first dose of EMBEDA at Visit 2.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EMBEDA Whole Capsule Treatment Period	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
EMBEDA Crushed in Solution Treatment Period	0 of 6 (0%)	6 of 6 (100%)	Not reported
EMBEDA Capsule Titration/Stabilization Period	0 of 14 (0%)	12 of 14 (85.7%)	Not reported
EMBEDA Capsules Maintenance Period	0 of 8 (0%)	1 of 8 (12.5%)	Not reported

Limitations and caveats (from the sponsor): Sponsor terminated study early on 10-Mar-2011.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23709323Setnik B, Roland CL, Goli V, Sommerville K, Webster L. A clinical trial to determine if corelease of morphine and naltrexone from crushed extended-release capsules induces withdrawal in opioid-dependent patients: a descriptive analysis of six patients. J Opioid Manag. 2013 Mar-Apr;9(2):139-50. doi: 10.5055/jom.2013.0155.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Chronic Pain

Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Clinical Opiate Withdrawal Scale (COWS) Score Greater Than or Equal to (≥) 13 in the Treatment Phase (time frame: Prior to dose, 0, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24 hours (hr) post-dose and unscheduled assessment (UA)). 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 NCT01100437, 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 13 Jul 2012.