- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543944
Improving Treatment Outcomes for Prescription Opioid Dependence (GBN)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be between the ages of 18-65
- be available to attend clinic 6 days a week for approximately 30-60 minutes per day during the first 4 3 weeks
- fulfill Diagnostic Statistical Manual-5 criteria for moderate to severe 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.
- submit a urine sample negative for benzodiazepines or barbiturates prior to starting the study.
Exclusion Criteria:
- report having had a severe adverse reaction to study medications
- have an unstable medical condition or stable medical condition that would interact with study medications or participation, including a current chronic pain or other medical condition that requires ongoing opioid agonist treatment (determined by physician assessment)
- have a major psychiatric disorder (psychosis, schizophrenia, bipolar)
- have major depression or anxiety disorder requiring psychoactive medication (as determined by physician)
- physiological dependence on alcohol or drugs other than opioids, tobacco or marijuana (as determined by physician assessment)
- are pregnant, plan to become pregnant or have inadequate birth control, if relevant
- report ongoing use of over-the-counter or prescription drug (including Maalox) that would have major interaction with study drugs
- have any of the following: liver function tests >3 times normal, blood urea nitrogen and Creatinine outside normal range; electrocardiogram abnormalities including but not limited to: bradycardia (<50 bpm); prolonged QT interval corrected for heart rate (>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; pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
Individuals with anxiety or depression will not be excluded unless they are taking prescription medication for their disorder under a physician's care or findings during screening indicate a need for immediate treatment determined by the study physician and/or the Columbia-Suicide Severity Rating Scale.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Gabapentin
Gabapentin started on day 3 of week 1, increased up to a maximum dose of 800 mg BID by day 3 of week 2 and maintained for 2 weeks followed by 5-day taper. Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3. During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4). |
N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detoxification and transition to depot naltrexone.
All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
|
Placebo Comparator: Placebo
Participants in this arm begin receiving placebo (microcrystalline cellulose) in twice daily capsules on day 3 of week 1 and continue to do so through the beginning of week 5. Buprenorphine (BUP) stabilization up to 12 mg (day 2 of week 1) then a 10-day BUP taper by the end of week 3. During week 4, detoxed subjects get 0.1 mg of clonidine followed by oral naltrexone (NTX) at 6.25 mg and another 6.25 mg (day 1), 25 mg (day 2) and 50 mg (day 3) then depot NTX injection (later on day 3 or day 4). |
All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
Microcrystalline cellulose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time
Time Frame: Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition)
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Thrice weekly urine samples obtained during weeks 1-3; data include assessments from week 1 day 1 through week 4 day 1 (up to 10 total samples per participant)
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Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NTX Transition Initiation
Time Frame: 3 days (wk 4 day 1 - week 4 day 3)
|
% of Participants who completed the detox and started the NTX transition
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3 days (wk 4 day 1 - week 4 day 3)
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Vivitrol Injection Receivers
Time Frame: 5 days (week 4 day 1 to week 4 day 5)
|
% of participants starting the NTX transition who received Vivitrol injection
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5 days (week 4 day 1 to week 4 day 5)
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Detox Phase Completers
Time Frame: 3 weeks (week 1-3)
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% of enrolled participants who completed the Detox Phase
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3 weeks (week 1-3)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Mancino, MD, University of Arkansas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Narcotic-Related Disorders
- Substance-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Narcotic Antagonists
- Anticonvulsants
- Antimanic Agents
- Alcohol Deterrents
- Sympatholytics
- Buprenorphine
- Gabapentin
- Naltrexone
- Clonidine
Other Study ID Numbers
- 203970
- R01DA039088 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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