Opioid-Related DisordersPhase 2NCT00142896
Tramadol to Reduce Opioid Withdrawal Symptoms
A Phase 2 study testing Tramadol, Naloxone and Morphine in people with Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Tramadol, Naloxone and Morphine
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Dec 2005
- Phase
- Phase 2
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets DSM-IV diagnostic criteria for opioid dependence
- Is in good physical health
- Qualifies for treatment with opioid agonist therapy (e.g., methadone)
- If female, must have a negative pregnancy test prior to study entry
Who cannot join
- Evidence of significant medical illness (e.g., insulin dependent diabetes mellitus)
- Evidence of significant psychiatric illness (e.g., schizophrenia)
- Currently seeking treatment for substance abuse
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University (BPRU) Bayview Campus
Baltimore, Maryland, 21224-6823
About this study
Official title: Withdrawal Suppression Efficacy of Tramadol
Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.
Read the detailed description
Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. Individuals with severe opioid withdrawal symptoms may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. Tramadol is a medication that is currently used to treat moderate to severe pain in individuals with cancer, joint pain, or pain resulting from surgery. Because of its pharmacological profile, tramadol may also be useful in treating opioid withdrawal. Further research is needed to confirm the benefits of tramadol for opioid addicts. The purpose of this study is to evaluate the effectiveness of tramadol at reducing opioid withdrawal symptoms in opioid-dependent individuals.
This 6-week inpatient study will enroll opioid-dependent individuals. Participants will be required to reside at the research clinic for the entire study. All participants will receive morphine maintenance treatment on a daily basis. Twice a week participants will take part in experimental challenge sessions in which they will be randomly assigned to receive varying doses of tramadol, naloxone, morphine, or placebo. These sessions will assess the ability of tramadol to suppress opioid withdrawal symptoms. Participants will complete performance tasks to measure psychomotor and cognitive functioning. Heart rate and blood pressure will be monitored throughout the experimental sessions. A specialized camera will also be used to assess pupillary response of the eyes. Questionnaires and self-reports will be completed to assess medication effects and withdrawal symptoms. Following the end of the study, all participants will be offered outpatient drug abuse treatment.
- Conditions
- Opioid-Related Disorders
- Being tested
- Tramadol, Naloxone, Morphine
- Keywords
- Opiate Addiction, Opiate Dependence
- 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.
TramadolDrug
NaloxoneDrug
MorphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions)
Opioid agonist effects (measured by Visual Analog Scale during the experimental sessions)
Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the experimental sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Eric C. Strain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142896
- Sponsor's protocol ID
- NIDA-18125-1
- Other IDs
- R01-18125-1, DPMC
- Status last verified
- Aug 2008
- First submitted
- 1 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal Suppression Efficacy of Tramadol
- ClinicalTrials.gov ID
- NCT00142896
- Acronym / sponsor ID
- NIDA-18125-1
- Conditions
- Opioid-Related Disorders
- Keywords
- Opiate Addiction, Opiate Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Feb 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 2 Sep 2005 (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.
Individuals with opioid addiction often experience serious withdrawal symptoms that may make relapse unavoidable. Tramadol, a medication that is currently used to treat pain caused by chronic conditions such as cancer or joint pain, may also be effective at reducing opioid withdrawal symptoms. This study will evaluate the effectiveness of tramadol at reducing withdrawal symptoms in individuals addicted to opioid drugs.
Detailed description
Opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. Individuals with severe opioid withdrawal symptoms may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. Tramadol is a medication that is currently used to treat moderate to severe pain in individuals with cancer, joint pain, or pain resulting from surgery. Because of its pharmacological profile, tramadol may also be useful in treating opioid withdrawal. Further research is needed to confirm the benefits of tramadol for opioid addicts. The purpose of this study is to evaluate the effectiveness of tramadol at reducing opioid withdrawal symptoms in opioid-dependent individuals.
This 6-week inpatient study will enroll opioid-dependent individuals. Participants will be required to reside at the research clinic for the entire study. All participants will receive morphine maintenance treatment on a daily basis. Twice a week participants will take part in experimental challenge sessions in which they will be randomly assigned to receive varying doses of tramadol, naloxone, morphine, or placebo. These sessions will assess the ability of tramadol to suppress opioid withdrawal symptoms. Participants will complete performance tasks to measure psychomotor and cognitive functioning. Heart rate and blood pressure will be monitored throughout the experimental sessions. A specialized camera will also be used to assess pupillary response of the eyes. Questionnaires and self-reports will be completed to assess medication effects and withdrawal symptoms. Following the end of the study, all participants will be offered outpatient drug abuse treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets DSM-IV diagnostic criteria for opioid dependence
- Is in good physical health
- Qualifies for treatment with opioid agonist therapy (e.g., methadone)
- If female, must have a negative pregnancy test prior to study entry
Key exclusion criteria (4 listed)
- Evidence of significant medical illness (e.g., insulin dependent diabetes mellitus)
- Evidence of significant psychiatric illness (e.g., schizophrenia)
- Currently seeking treatment for substance abuse
- Pregnant or breastfeeding
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 |
|---|---|---|
| Tramadol | Drug | – |
| Naloxone | Drug | – |
| Morphine | Drug | – |
Primary outcome
Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions)
Opioid agonist effects (measured by Visual Analog Scale during the experimental sessions)
Physiological effects (measured by pulse oximeter, blood pressure, heart rate, and pupillary camera during the experimental sessions)
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 Jan 2017.
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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.
Eric C. Strain, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol, Naloxone and Morphine in people with Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 4 inclusion and 4 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 Jan 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 phase mean?
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?
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?
Opioid withdrawal symptoms (measured by Visual Analog Scale during the experimental sessions). The study lists 3 primary outcomes in all. 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 Jan 2017.