Opioid DependencePhase 2DetoxNCT01262092
Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
A Phase 2 study testing Buprenorphine in people with Opioid Dependence and Opioid Withdrawal, run by University of Arkansas at 1 site in United States.
Trial summary
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
- What is being tested?
- Buprenorphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2012
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Availability to attend clinic 6 days a week for approximately 30-60 minutes.
- Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
- Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.
Who cannot join
- Unstable medical condition or stable medical condition that would interact with study medications or participation.
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
- Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
- Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
- Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
- EKG abnormalities including but not limited to: bradycardia (<60 bpm); prolonged QTc interval (>450 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
- Physical dependence on alcohol or drugs other than opioids or tobacco (as determined by physician assessment).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.
- Conditions
- Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
- Being tested
- Buprenorphine
- Keywords
- opioid dependent, detoxification, buprenorphine, suboxone, opiate
- 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
Also called Neurontin, Suboxone,
Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night. Receives: Drug: Buprenorphine |
| Placebo | Placebo comparator | Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening Receives: Drug: Buprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit Opioid Use as Determine by Urine Dipsticks
urine data are from those obtained during the buprenorphine taper
Measured: 3x weekly during wks 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionJan 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.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alison Oliveto, Ph.D., Principal investigator, UAMS Center for Addiction Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262092
- Sponsor's protocol ID
- R01-DA010017-pilot
- Other IDs
- 112714, R01DA010017
- Acronym
- Detox
- Status last verified
- Jun 2013
- First submitted
- 15 Dec 2010
- Last updated
- 21 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gabapentin Versus Placebo on Buprenorphine Detoxification of Opioid-dependent Individuals
- ClinicalTrials.gov ID
- NCT01262092
- Acronym / sponsor ID
- Detox / R01-DA010017-pilot
- Conditions
- Opioid Dependence, Opioid Withdrawal, Opioid Detoxification
- Keywords
- opioid dependent, detoxification, buprenorphine, suboxone, opiate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 21 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves inducting treatment seeking opioid dependent participants onto buprenorphine. Once the participant reaches a stable dose they will receive either placebo or gabapentin to determine if gabapentin helps ease withdrawal symptoms while the participant undergoes a 10-day buprenorphine detoxification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: BuprenorphineBuprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night. |
| Placebo | Placebo comparator | Drug: BuprenorphineBuprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Availability to attend clinic 6 days a week for approximately 30-60 minutes.
- Participants must fulfill DSM-IV criteria for opioid dependence. These criteria will be ascertained in the following manner: the physician will determine whether the individual is appropriate based on several clinical assessments that are routinely employed by methadone program physicians, including history and severity of opioid use, presence of track marks, prior treatment history, self-reported and/or observed signs and symptoms of opioid withdrawal. If any individual's degree of opioid dependence is questionable, that person will be excluded from further consideration as a participant.
- Participants must submit a urine negative for drugs of abuse other than opioids prior to starting the study.
Key exclusion criteria (7 listed)
- Unstable medical condition or stable medical condition that would interact with study medications or participation.
- History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
- Pregnancy or plans to become pregnant or inadequate birth control (adequate birth control includes abstinence, condoms, birth control pills, etc).
- Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug (including Maalox) that would have major interaction with drugs to be tested.
- Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
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 |
|---|---|---|
| BuprenorphineAlso: Neurontin, Suboxone,Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin. | Drug | Gabapentin, Placebo |
Primary outcome
Illicit Opioid Use as Determine by Urine Dipsticks
Time frame: 3x weekly during wks 3 and 4
urine data are from those obtained during the buprenorphine taper
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alison Oliveto, Ph.D. principal investigator
UAMS Center for Addiction Research
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 Buprenorphine in people with Opioid Dependence and Opioid Withdrawal, run by University of Arkansas 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 3 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 21 Jun 2013. 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 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?
Yes. Results are posted in the registry (first posted 21 Jun 2013). 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?
Illicit Opioid Use as Determine by Urine Dipsticks (time frame: 3x weekly during wks 3 and 4). 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 21 Jun 2013.