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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA008045 | 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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Buprenorphine is an approved medication for the treatment of opioid dependence. It is typically administered once daily as a sublingual tablet combined with naloxone (i.e., Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical dependence. In addition, some research suggests there is relatively little withdrawal following cessation of chronically administered buprenorphine. This study will examine the spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine in opioid dependent individuals. This study will assess the characteristics and time course of withdrawal using subject-rated and observer-rated measures of opioid withdrawal. Physiologic measures and psychomotor performance will be collected during chronic opioid administration and during placebo administration (i.e., during spontaneous withdrawal). Particular attention will be paid to the differences (if any) in sleep disturbances and withdrawal associated hyperalgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morphine, then Buprenorphine | Experimental | Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above. |
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| Buprenorphine, then Morphine | Experimental | Healthy, out of treatment opioid-dependent residential volunteers (N=7) were randomized to receive buprenorphine (32 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day). Participants then underwent an 18-day period of spontaneous withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (30 mg of morphine four times per day) followed by a second 18-day period of spontaneous withdrawal identical to the withdrawal period described above. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| buprenorphine | Drug | parenteral buprenorphine may be administered at multiple times each day |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) | Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings. | Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS) | Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being "None" to 100 being "Extremely". The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine. | Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Strain, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Pharmacology Research Unit | Baltimore | Maryland | 21224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24227768 | Result | Tompkins DA, Smith MT, Mintzer MZ, Campbell CM, Strain EC. A double blind, within subject comparison of spontaneous opioid withdrawal from buprenorphine versus morphine. J Pharmacol Exp Ther. 2014 Feb;348(2):217-26. doi: 10.1124/jpet.113.209478. Epub 2013 Nov 13. |
| Label | URL |
|---|---|
| A double Blind, within Subjects Comparison of Spontaneous Opioid Withdrawal from Buprenorphine versus Morphine | View source |
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The study site was an in-patient research-based clinic affiliated with the Johns Hopkins University School of Medicine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Morphine First, Then Buprenorphine | Participants randomized to receive morphine (120 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using buprenorphine (32 mg/day i.m.) with the same time course |
| FG001 | Buprenorphine First, Then Morphine | Participants randomized to receive buprenorphine (32 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using morphine (120 mg/day i.m.) with the same time course |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| First 18-day Withdrawal |
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| Second Intervention |
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| Second 18-day Withdrawal |
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| ID | Title | Description |
|---|---|---|
| BG000 | Within Subjects Design | Participants received both study drugs (buprenorphine and morphine) in a randomized sequence. |
| Units | Counts |
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| Participants |
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| 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 | Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) | Clinical Opiate Withdrawal Scale (COWS) is an observer-rated tool for quantifying opioid withdrawal. The scale ranges from 0 to 48: Scores 5 to 12 are mild, 13 to 24 are moderate, 25 to 36 are moderately severe, and over 36 are severe withdrawal. The scores on this repeated measure were analyzed by a two-factor ANOVA for mean peak daily COWS ratings. | Posted | Mean | Full Range | units on a scale | Average mean peak opioid withdrawal thirty minutes before and after injection assessed up to 59 days |
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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 | All Participants | The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
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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 |
|---|---|
| D002047 | Buprenorphine |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| morphine | Drug | parenteral morphine may be administered multiple times each day |
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| Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine. | Average mean peak sleep assessed once a week for up to 8 weeks |
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| Participants |
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| Gender | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Mean Daily Peak Pain Ratings Assessed by the Visual Analog Scale (VAS) | Visual Analog Scale (VAS) measures subjective ratings on pain. The scale on this measurement ranges from 0 being "None" to 100 being "Extremely". The results below reflect the subjective measurements of pain taken from day 0 to day 18 of withdrawal from both morphine and buprenorphine. | Posted | Mean | Full Range | units on a scale | Average mean daily peak pain ratings assessed from day 0 to day 18 during the 18 day withdrawal period |
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| Secondary | Mean Peak Sleep Assessed by Pittsburgh Sleep Quality Index (PSQI) | Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, total scores range from 0 (better) to 21(worse). The data that has been reported reflects the peak scores on the PSQI during the withdrawal period from both morphine and buprenorphine. | Posted | Mean | Standard Error | units on a scale | Average mean peak sleep assessed once a week for up to 8 weeks |
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| 0 |
| 12 |
| 4 |
| 12 |
| Indigestion | Gastrointestinal disorders |
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| Lacrimation Increased | Eye disorders |
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| Chills | General disorders |
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| Insomnia | Psychiatric disorders |
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| Headache | General disorders |
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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 |
| D009022 | Morphine Derivatives |
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