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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA027068 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol 200 mg then placebo | Experimental | Tramadol 200 mg daily for 1 week then placebo given for 1 week |
|
| Placebo for two weeks | Placebo Comparator | Medication |
|
| Tramadol 600 mg then placebo | Experimental | Tramadol 600 mg daily given for 1 week given then placebo given for 1 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Oral Medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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 | 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. | Days 8-13 (all groups now on placebo) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Lofwall, M.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23755929 | Result | 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. |
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Persons screening who did not meet inclusion/ exclusion criteria were not enrolled.
Persons who did not complete the study were not included in analyses. The study was designed as an efficacy study that a priori stated it would enroll until 12 persons in each group completed the study and analyse only completers. No serious AEs in noncompleters.
Outpatient screening. Recruitment by advertisement and word or mouth.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tramadol 200 mg Daily | Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week |
| FG001 | Placebo | Placebo given for two weeks |
| FG002 | Tramadol 600 mg Daily | Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study was a priori defined to evaluate only completers. There were 12 completers in each of the three study arms. We retained the description of the completers because it corresponds to the primary outcomes results that are reported (and this is what was proposed a priori and approved by NIDA review).
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| ID | Title | Description |
|---|---|---|
| BG000 | Tramadol 200 mg | Medication: Extended release tramadol for 1 week and then placebo given for 1 week |
| BG001 | Placebo | Medication: Placebo given for two weeks |
| 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 | 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 | The primary analysis was ANOVA with day and treatment arm as factors. The outcome measure described below is the mean across the days listed. | Posted | Mean | Standard Error | units on a scale | Days 1-7 |
|
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There were no serious adverse events for anyone enrolled (completers and non-completers). The remaining adverse events are reported from both completers and non-completers.
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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 | Tramadol 200 mg | Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| unsteady urine flow without dysuria | Renal and urinary disorders | Systematic Assessment | Occurred in a completer |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Lofwall, MD, Associate Professor | University of Kentucky College of Medicine | 8593239321 | michelle.lofwall@uky.edu |
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Drug | Oral Medication |
|
|
| BG002 | Tramadol 600 mg | Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Tramadol 600 mg Daily |
Medication: Extended release tramadol |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | Mean doses per day | Days 1-7 |
|
|
|
| Primary | 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 | 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. | Posted | Mean | Standard Error | units on a scale | days 8-13 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Error | mean # of doses per day | Days 8-13 (all groups now on placebo) |
|
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| EG001 | Placebo | Medication: Placebo for 2 weeks | 0 | 19 | 1 | 19 |
| EG002 | Tramadol 600 mg | Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week | 0 | 17 | 2 | 17 |
|
| sore throat/strep B | Infections and infestations | Systematic Assessment | Occurred in a completer |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment | Occurred in a completer |
|
| fleeting chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Occurred in a completer |
|
| left shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Pre-existing condition -- pain due to old MVA whereby shoulder was hurt. Occurred in a non-completer. |
|
| tooth pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Cracked right front tooth prior to admission to study - now with mild pain in that tooth. Occurred in a non-completer. |
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| flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | right sided flank pain that started 2 days prior to randomization, mild severity, occurs when twisting body. Occurred in a non-completer. |
|
| sore throat with cough | Infections and infestations | Systematic Assessment | Occurred in a non-completer. |
|
| athletes foot | Infections and infestations | Systematic Assessment | Occurred in a non-completer. |
|
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| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |