Substance Withdrawal SyndromePhase 2/3NCT00980044

Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

A Phase 2/3 study testing Tramadol in people with Substance Withdrawal Syndrome, run by Michelle Lofwall 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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Substance Withdrawal Syndrome
What is being tested?: Tramadol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Mar 2012
Phase: Phase 2/3
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Addicted to opioids

Who cannot join

Any major medical or psychiatric disorder that would be contraindicated for participation

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky
Lexington, Kentucky, 40502

Other trials in United States

About this study

Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.

Conditions: Substance Withdrawal Syndrome
Being tested: Tramadol, Placebo
Medical subject headings: Substance Withdrawal Syndrome

What participants receive

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

TramadolDrug
Also called Brand name example: Ultram
Oral Medication
PlaceboDrug
Also called Placebo is like a sugar pill
Oral Medication

Study groups in NCT00980044
Study group	Role	What they receive
Tramadol 200 mg then placebo	Experimental	Tramadol 200 mg daily for 1 week then placebo given for 1 week Receives: Drug: Tramadol
Placebo for two weeks	Placebo comparator	Medication Receives: Drug: Placebo
Tramadol 600 mg then placebo	Experimental	Tramadol 600 mg daily given for 1 week given then placebo given for 1 week Receives: Drug: Tramadol

What is being measured

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

Subjective Opioid Withdrawal Total Adjective Score
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Measured: Days 1-7
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Measured: Days 1-7
Subjective Opioid Withdrawal Adjective Total Score Week 2
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Measured: days 8-13
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Measured: Days 8-13 (all groups now on placebo)

Timeline

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

Oct 2009Mar 2012

First posted18 Sep 2009 (estimated)
Study startOct 2009
Primary completionFeb 2012
Study completionMar 2012

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 Substance Withdrawal SyndromeStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00980044
Sponsor's protocol ID: 09-0489
Other IDs: R01DA027068
Status last verified: Mar 2017
First submitted: 17 Sep 2009
Last updated: 5 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lofwall MR, Babalonis S, Nuzzo PA, Siegel A, Campbell C, Walsh SL. Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):188-97. doi: 10.1016/j.drugalcdep.2013.05.010. Epub 2013 Jun 4.
PubMed 23755929

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

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All Substance Withdrawal Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal
ClinicalTrials.gov ID: NCT00980044
Acronym / sponsor ID: 09-0489
Conditions: Substance Withdrawal Syndrome
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Michelle LofwallUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Oct 2009
Primary completion: Feb 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 18 Sep 2009 (estimated)
Results: Posted 3 Dec 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Tramadol 200 mg then placebo	Experimental	Drug: TramadolTramadol 200 mg daily for 1 week then placebo given for 1 week
Placebo for two weeks	Placebo comparator	Drug: PlaceboMedication
Tramadol 600 mg then placebo	Experimental	Drug: TramadolTramadol 600 mg daily given for 1 week given then placebo given for 1 week

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Addicted to opioids

Key exclusion criteria (1 listed)

Any major medical or psychiatric disorder that would be contraindicated for participation

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
TramadolAlso: Brand name example: UltramOral Medication	Drug	Tramadol 200 mg then placebo, Tramadol 600 mg then placebo
PlaceboAlso: Placebo is like a sugar pillOral Medication	Drug	Placebo for two weeks

Primary outcome

Subjective Opioid Withdrawal Total Adjective Score
Time frame: Days 1-7
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present. T
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1
Time frame: Days 1-7
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.
Subjective Opioid Withdrawal Adjective Total Score Week 2
Time frame: days 8-13
range of scores is 0-84; low scores indicate no opioid withdrawal, higher scores indicating more opioid withdrawal present
Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2
Time frame: Days 8-13 (all groups now on placebo)
There were four medications (acetaminophen for aches/pains, zolpidem for trouble sleeping, bismuth subsalicylate for diarrhea, and alumina/magnesia/simethicone for nausea/upset stomach) available to all volunteers in all treatment arms to help relieve any withdrawal symptoms that were not relieved by the blinded tramadol/placebo doses.

Results and safety

Results posted to the registry on 3 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tramadol 200 mg Daily	17	12
Placebo	19	12
Tramadol 600 mg Daily	17	12

Primary outcome: Subjective Opioid Withdrawal Total Adjective Score

Time frame: Days 1-7. Mean (Standard Error). Unit: units on a scale

Measure	Tramadol 200 mg Daily n = 12	Placebo n = 12	Tramadol 600 mg Daily n = 12
Value	5.8 (0.1)	7.7 (0.1)	6.9 (0.1)

Population analysed: The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.

Primary outcome: Total Number of Breakthrough Withdrawal Medication Doses Taken Week 1

Time frame: Days 1-7. Mean (Standard Error). Unit: Mean doses per day

Measure	Tramadol 200 mg Then Placebo n = 12	Placebo for Two Weeks n = 12	Tramadol 600 mg Then Placebo n = 12
Value	1.8 (0.2)	2.5 (0.2)	3.1 (0.3)

Population analysed: These are data from week 1 -- the 12 people who completed this week in each group. This is the analysis that was specified at the start of the study. The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed.

Primary outcome: Subjective Opioid Withdrawal Adjective Total Score Week 2

Time frame: days 8-13. Mean (Standard Error). Unit: units on a scale

Measure	Tramadol 200 mg Then Placebo n = 12	Placebo for Two Weeks n = 12	Tramadol 600 mg Then Placebo n = 12
Value	2.7 (0.2)	2.9 (0.2)	2.7 (0.1)

Population analysed: The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean total withdrawal score across the days listed.

Primary outcome: Total Number of Breakthrough Withdrawal Medication Doses Taken Week 2

Time frame: Days 8-13 (all groups now on placebo). Mean (Standard Error). Unit: mean # of doses per day

Measure	Tramadol 200 mg Then Placebo n = 12	Placebo for Two Weeks n = 12	Tramadol 600 mg Then Placebo n = 12
Value	1.8 (0.2)	1.6 (0.1)	3.2 (0.2)

Population analysed: The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean number of doses/day across the days listed.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tramadol 200 mg	0 of 17 (0%)	2 of 17 (11.8%)	Not reported
Placebo	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Tramadol 600 mg	0 of 17 (0%)	2 of 17 (11.8%)	Not reported

Limitations and caveats (from the sponsor): The study was designed to analyze only completers (12 subjects per group so the description of study participant characteristics and outcomes are from these a prior defined n=36 (12 per group) completers.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23755929Lofwall MR, Babalonis S, Nuzzo PA, Siegel A, Campbell C, Walsh SL. Efficacy of extended-release tramadol for treatment of prescription opioid withdrawal: a two-phase randomized controlled trial. Drug Alcohol Depend. 2013 Nov 1;133(1):188-97. doi: 10.1016/j.drugalcdep.2013.05.010. Epub 2013 Jun 4.

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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.

Michelle Lofwall, M.D. principal investigator

University of Kentucky

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Tramadol in people with Substance Withdrawal Syndrome, run by Michelle Lofwall 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 1 inclusion and 1 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 5 Apr 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. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Dec 2014). 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?

Subjective Opioid Withdrawal Total Adjective Score (time frame: Days 1-7). 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 NCT00980044, 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 5 Apr 2017.