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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00037871 | Other Identifier | JHUSOM IRB | |
| R01DA018125 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a study of tramadol as an agent for short-term opioid withdrawal treatment. A randomized, double blind clinical trial comparing the efficacy and safety of tramadol to clonidine and buprenorphine in the short-term treatment of opioid withdrawal will be conducted. Opioid dependent participants will be treated on a residential unit. The primary outcome measure is opioid withdrawal symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| buprenorphine | Active Comparator | Sublingual buprenorphine/naloxone tablets (or placebo) |
|
| clonidine | Active Comparator | Oral clonidine tablets (or placebo) |
|
| tramadol ER | Experimental | Oral tramadol tablets (or placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/naloxone | Drug | up to 8/2 mg Sublingual (SL) per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period. | Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal. | 14 days total |
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Inclusion/Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric C. Strain, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University (BPRU) Bayview Campus | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28700791 | Derived | Dunn KE, Tompkins DA, Bigelow GE, Strain EC. Efficacy of Tramadol Extended-Release for Opioid Withdrawal: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):885-893. doi: 10.1001/jamapsychiatry.2017.1838. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine | Sublingual buprenorphine/naloxone tablets (or placebo) Buprenorphine/naloxone: up to 8/2 mg SL per day |
| FG001 | Tramadol ER | Oral tramadol tablets (or placebo) Tramadol ER: up to 600 mg per day |
| FG002 | Clonidine | Oral clonidine tablets (or placebo) Clonidine: up to 0.8 mg per day (oral) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine | Sublingual buprenorphine/naloxone tablets (or placebo) Buprenorphine/naloxone: up to 8/2 mg SL per day |
| BG001 | Tramadol ER | Oral tramadol tablets (or placebo) Tramadol ER: up to 600 mg per day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period. | Outcomes represent mean peak withdrawal as rated on the Clinical Opiate Withdrawal Scale (COWS) total score. Withdrawal was collected 7 times daily and daily peak values were identified for each participant and averaged together as a function of group. Primary outcomes were mean peak results from the 7-day taper period and first 7 days post-taper. The COWS is an 11-item observer-rated measure of opioid withdrawal severity. Items are rated on individual Likert scales and the total score range is 0-47. Higher values indicate more severe withdrawal. | Repeated measures ANOVA | Posted | Mean | Standard Error | units on a scale | 14 days total |
|
Adverse events are reported from the Taper and Post-Taper periods (approximately 18-19 days). No Adverse Events reported from Stabilization phase (7-10 day period) since this occurred prior to primary experimental manipulation and randomization to study drug (clonidine, tramadol, buprenorphine).
Standard terminology
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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 | Buprenorphine | Sublingual buprenorphine/naloxone tablets (or placebo) Buprenorphine/naloxone: up to 8/2 mg SL per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric C. Strain, MD | Johns Hopkins University, School of Medicine | 410-550-1191 | estrain1@jhmi.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 |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| D003000 | Clonidine |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Clonidine | Drug | up to 0.8 mg per day (oral) |
|
|
| Tramadol ER | Drug | up to 600 mg per day |
|
|
| BG002 | Clonidine | Oral clonidine tablets (or placebo) Clonidine: up to 0.8 mg per day (oral) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | percentage of participants |
|
| OG001 | Tramadol ER | Oral tramadol tablets (or placebo) Tramadol ER: up to 600 mg per day |
| OG002 | Clonidine | Oral clonidine tablets (or placebo) Clonidine: up to 0.8 mg per day (oral) |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 28 |
| 31 |
| EG001 | Tramadol ER | Oral tramadol tablets (or placebo) Tramadol ER: up to 600 mg per day | 0 | 36 | 0 | 36 | 31 | 36 |
| EG002 | Clonidine | Oral clonidine tablets (or placebo) Clonidine: up to 0.8 mg per day (oral) | 0 | 36 | 0 | 36 | 32 | 36 |
| Drowsiness | General disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Lethargy | General disorders | Non-systematic Assessment | stupor or coma from disease |
|
| Malaise | General disorders | Non-systematic Assessment | uneasiness or indisposition |
|
| Abdominal Pain | General disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment | High heart rate |
|
| Abdominal Cramp | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flatulance | Gastrointestinal disorders | Non-systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | pain in joint |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cramp Lower Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Ache | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain Lower Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Agitation | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Fatigue | Nervous system disorders | Non-systematic Assessment |
|
| Insomnia | Nervous system disorders | Non-systematic Assessment |
|
| Irritability | Nervous system disorders | Non-systematic Assessment |
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| Restlessness | Nervous system disorders | Non-systematic Assessment |
|
| Shaky | Nervous system disorders | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | Non-systematic Assessment |
|
| Cough | General disorders | Non-systematic Assessment | non-productive |
|
| Nasal Congestion | General disorders | Non-systematic Assessment |
|
| Rhinitis | General disorders | Non-systematic Assessment |
|
| Rhinorrhea | General disorders | Non-systematic Assessment |
|
| Yawning | General disorders | Non-systematic Assessment | Excessively |
|
| Piloerection | General disorders | Non-systematic Assessment |
|
| Sweat Increased | General disorders | Non-systematic Assessment |
|
| Hot Flashes | Eye disorders | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | Non-systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |