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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DA008045-08 | U.S. NIH Grant/Contract | View source | |
| R01DA008045 | U.S. NIH Grant/Contract | View source | |
| DPMCDA | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a residential study that looks at the effects of buprenorphine in persons who abuse but are not dependent on opioids. Animal studies show that very high doses of buprenorphine produce less effects than mid-range doses. This suggests that buprenorphine can be a very safe medication. However, no studies in humans have tested higher doses in a similar way. The goal of this study is to show the effects of single doses of buprenorphine, across a range of doses, in persons who are not physically dependent on opioids (but do abuse opioids).
Preclinical studies have demonstrated for a variety of measures that buprenorphine has a bell-shaped dose response curve. However, human studies with buprenorphine have not shown such an effect, although controlled studies have generally not tested higher acute doses of buprenorphine. Current clinical recommendations generally place an upper limit of daily buprenorphine dosing at 32 mg of sublingual tablets, although considerably higher acute doses have been administered to humans (primarily in clinical studies of less than daily dosing). Determining the relationship between higher doses of buprenorphine in humans and effects produced would be valuable; it would be scientifically interesting to demonstrate a bell-shaped curve in humans, and it would help guide clinical practice (for example, with respect to dosing, safety, and side effect considerations. The purpose of this study is to characterize the dose response curve for buprenorphine in humans, utilizing acute single doses of parenteral buprenorphine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
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| Morphine 15 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
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| Morphine 30 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
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| Buprenorphine 8 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
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| Buprenorphine 16 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS) | Opioid agonist effects measured by peak change from baseline drug effect visual analog scale. Scores range from 0 (not all all) to 100 (extremely); higher scores indicate a stronger drug effect. | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
| Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST) | Digit Symbol Substitution Test (DSST) is a sub-test within the Wechsler Adult Intelligence Scale and is frequently used to assess psychomotor performance changes associated with drug effects. The higher the percent correct on this measure the better the performance. | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
| Psychomotor/Cognitive Performance Effects Assessed by Trails B | The Trails B task specifically measures set shifting and executive functioning within the Trail-Making Test. Part B consists of 25 circles distributed over a sheet of paper. Participants are asked to connect the circles in an ascending pattern, alternating between numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
| Physiologic Effects as Assessed by Blood Pressure | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) | |
| Physiologic Effects as Assessed by Heart Rate | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) | |
| Physiologic Effects as Assessed by Body Temperature |
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Inclusion Criteria:
1. current opioid abuse but not physically dependent on opioids
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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Condition 1 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, B60, M15, M30, P. |
| FG001 | Condition 2 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, M15, B48, P, B60, M30. |
| FG002 | Condition 3 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, B32, B48, M30, B60, P, M15. |
| FG003 | Condition 4 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, M15, B16, P, B32, M30, B48, B60. |
| FG004 | Condition 5 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): B8, B16, M30, B32, P, B48, M15, B60. |
| FG005 | Condition 6 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, P, B8, M30, B16, B32, P, B48, B60. |
| FG006 | Condition 7 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M30, B8, P, B16, M15, B32, B48, B60. |
| FG007 | Condition 8 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): P, M30, M15, B8, B16, B32, B48, B60. |
| FG008 | Condition 9 | Participants receive single doses of intramuscular (IM) test drugs; there were 9 possible test drugs (placebo [P], 2 doses of morphine [M], 5 doses of buprenorphine [B]), with at least 3 days between IM injections. For this condition, the order of dosing was (numbers represent doses in mg): M15, B8, B16, B32, M30, P, B48, B60. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Study Participants |
| Units | Counts |
|---|---|
| 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 | Peak Change From Baseline in Drug Effect Assessed by Visual Analog Scale (VAS) | Opioid agonist effects measured by peak change from baseline drug effect visual analog scale. Scores range from 0 (not all all) to 100 (extremely); higher scores indicate a stronger drug effect. | Subjects who completed all test conditions. | Posted | Mean | Standard Error | units on a scale | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
|
Adverse event data were collected during time participants resided on the residential unit (target period of 6-7 weeks).
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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 | Placebo Intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric C. Strain, M.D. | Johns Hopkins University School of Medicine | 410-550-1191 | ecsgss@aol.com |
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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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| Buprenorphine 32 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
|
| Buprenorphine 48 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
|
| Buprenorphine 60 | Experimental | All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). |
|
| Morphine | Drug | Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind |
|
| Placebo | Drug | Intramuscular; double blind; once per week |
|
| Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
| Physiologic Effects as Assessed by Oxygen Saturation | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
| Physiologic Effects as Assessed by Pupil Diameter | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
| Withdrawal by Subject |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Buprenorphine 8 mg |
| OG004 | Buprenorphine 16 mg |
| OG005 | Buprenorphine 32 mg |
| OG006 | Buprenorphine 48 mg |
| OG007 | Buprenorphine 60 mg |
|
|
| Primary | Psychomotor/Cognitive Performance Effects Assessed by Digit Symbol Substitution Test (DSST) | Digit Symbol Substitution Test (DSST) is a sub-test within the Wechsler Adult Intelligence Scale and is frequently used to assess psychomotor performance changes associated with drug effects. The higher the percent correct on this measure the better the performance. | Posted | Mean | Standard Deviation | percentage of correct answers | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
|
|
|
| Primary | Psychomotor/Cognitive Performance Effects Assessed by Trails B | The Trails B task specifically measures set shifting and executive functioning within the Trail-Making Test. Part B consists of 25 circles distributed over a sheet of paper. Participants are asked to connect the circles in an ascending pattern, alternating between numbers and letters (i.e., 1-A-2-B-3-C, etc.). Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. | Subjects who completed all test conditions. | Posted | Mean | Standard Deviation | minutes | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
|
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| Primary | Physiologic Effects as Assessed by Blood Pressure | Subjects who completed all test conditions. | Posted | Mean | Standard Deviation | mmHg | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
|
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| Primary | Physiologic Effects as Assessed by Heart Rate | Subjects who completed all test conditions. | Posted | Mean | Standard Deviation | beats/min | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
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| Primary | Physiologic Effects as Assessed by Body Temperature | Subjects who completed all test conditions. | Posted | Mean | Standard Deviation | Degrees Fahrenheit | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
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| Primary | Physiologic Effects as Assessed by Oxygen Saturation | Subjects who completed all test conditions. | Posted | Mean | Standard Deviation | percentage of saturated hemoglobin | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
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| Primary | Physiologic Effects as Assessed by Pupil Diameter | Subjects who completed all test conditions. | Posted | Mean | Standard Deviation | millimeters | Each experimental test session (8 experimental test sessions assessed for up to 6-7 weeks) |
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| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Morphine Intervention | 0 | 12 | 0 | 12 |
| EG002 | Buprenorphine Intervention | 0 | 12 | 0 | 12 |
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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 |
| Diastolic Blood Pressure |
|