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| ID | Type | Description | Link |
|---|---|---|---|
| 112714 | Other Identifier | UAMS IRB | |
| R01DA010017 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Illicit Opioid Use as Determine by Urine Dipsticks | urine data are from those obtained during the buprenorphine taper | 3x weekly during wks 3 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Oliveto, Ph.D. | UAMS Center for Addiction Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
On Tuesday of Week 1, participants were randomized into treatment groups based on withdrawal symptoms score, sex and primary opioid of abuse using an urn randomization procedure. This was done to ensure that groups are balanced with respect to potential prognostic factors.
Thirty treatment-seeking opioid-dependent individuals were recruited from Central Arkansas by ads, word-of-mouth and referrals in October 2010 and January 2011-December of 2011. An experienced research staff member obtained informed consent interviewed subjects in a private office on the 4th floor of the Psychiatric Research Institute.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night. |
| FG001 | Placebo | Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Buprenorphine+Gabapentin/Plac Induction |
|
| |||||||||||||||||||||
| Buprenorphine Taper |
| ||||||||||||||||||||||
| Gabapentin Taper |
|
analysis was based on those starting the buprenorphine detox except for one subject in the gabapentin arm (evidence of noncompliance with medication procedures and diversion)
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night. |
| BG001 | Placebo | Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Illicit Opioid Use as Determine by Urine Dipsticks | urine data are from those obtained during the buprenorphine taper | Those who started the bup detox (N=24) excluding 1 subjects' data in the gabapentin group due to evidence of noncompliance with medication procedures and diversion (N=1). | Posted | Mean | Standard Error | % of urines positive for opioids | 3x weekly during wks 3 and 4 | urine samples | Participants |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness/Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Oliveto | University of Arkansas for Medical Sciences | 501-526-8441 | olivetoalison@uams.edu |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D000077206 | Gabapentin |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| NOT COMPLETED |
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| NOT COMPLETED |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
|
|
| 0 |
| 16 |
| 10 |
| 16 |
| EG001 | Placebo | Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening | 0 | 14 | 4 | 14 |
| nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Sleepiness/Fatigue/Somnulence | Psychiatric disorders | Systematic Assessment |
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| Vivid, disturbing dreams, nightmares | Psychiatric disorders | Systematic Assessment |
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| muscle twitches/cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
|
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009270 | Naloxone |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |