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Opioid AbusePhase 1/2NCT01136356

A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals

A Phase 1/2 study testing buprenorphine and morphine in people with Opioid Abuse and Opioid Dependence, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Opioid Abuse, Opioid Dependence
What is being tested?
buprenorphine and morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
Jul 2010to Mar 2012
Phase
Phase 1/2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Be adults ranging in age from 21-55 years old.
  • Be dependent on opioids.
  • Be willing to accept or desiring of opioid detoxification.
  • He healthy as determined by medical screen, history, and vitals.
  • Be without significant psychiatric illness besides drug dependence.
  • Be without chronic pain.
  • Fluent in English (speaking, writing, and reading).
  • Be willing and able to participate.

Who cannot join

  • Previous documented allergy to buprenorphine or morphine.
  • Are dependent on other drugs besides opioids and tobacco.
  • Have current history of significant use of alcohol or sedative/hypnotics.
  • Have evidence of significant medical (e.g., insulin dependent diabetes mellitus) or psychiatric (e.g., schizophrenia) illness.
  • Are pregnant (female volunteers will receive a pregnancy test before participation in the study and routinely during the study).
  • Have an abnormal or prolongation of the corrected QT interval (QTc) on a baseline electrocardiogram (ECG).
  • Are seeking treatment for their substance dependence.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Behavioral Pharmacology Research Unit

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.

Being tested
buprenorphine, morphine
Keywords
opioid pharmacology, buprenorphine, morphine, withdrawal, human research
Medical subject headings
Opioid-Related Disorders

What participants receive

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

  • buprenorphineDrug

    parenteral buprenorphine may be administered at multiple times each day

  • morphineDrug

    parenteral morphine may be administered multiple times each day

Study groups in NCT01136356
Study groupRoleWhat they receive
Morphine, then BuprenorphineExperimentalHealthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.
Receives: Drug: buprenorphine; Drug: morphine
Buprenorphine, then MorphineExperimentalHealthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day). Participants then underwent an 18-day period of spontaneous withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above.
Receives: Drug: buprenorphine; Drug: morphine

What is being measured

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

  1. Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS)

    Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings.

    Measured: Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days

Secondary outcomes (2)

  1. Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS)

    Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being "None" to 100 being "Extremely". The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine.

    Measured: Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period

  2. Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI)

    Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine.

    Measured: Average mean peak sleep assessed once a week for up to 8 weeks

Timeline

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

  1. First posted3 Jun 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01136356
Sponsor's protocol ID
NIDA-08045-9
Other IDs
R01DA008045, DPMC
Status last verified
Jan 2017
First submitted
2 Jun 2010
Last updated
3 Mar 2017
Data monitoring committee
No

Publications

  • Tompkins DA, Smith MT, Mintzer MZ, Campbell CM, Strain EC. A double blind, within subject comparison of spontaneous opioid withdrawal from buprenorphine versus morphine. J Pharmacol Exp Ther. 2014 Feb;348(2):217-26. doi: 10.1124/jpet.113.209478. Epub 2013 Nov 13.

    PubMed 24227768

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing buprenorphine and morphine in people with Opioid Abuse and Opioid Dependence, run by Johns Hopkins University at 1 site in United States.

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 8 inclusion and 7 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 3 Mar 2017. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Mar 2017). 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?

Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) (time frame: Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days). 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 NCT01136356, 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 3 Mar 2017.

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