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The investigators' recently completed study has provided the first evidence that administration of the medication propranolol, following exposure to cocaine cues, can alter drug-associated memories and reduce craving and other drug cue-elicited responses in cocaine addicted persons. The investigators will attempt to augment this effect by a) doubling the number of propranolol-medicated cocaine cue exposure (CCE) retrieval sessions and b) increasing the dose of propranolol. It is expected that propranolol treated groups, relative to placebo treated groups, will evidence greater reduction of craving, cue reactivity and cocaine use during follow-up cocaine cue exposures. Also, these effects will be greater for those who receive 80mg of propranolol as opposed to 40mg.
Three groups of CD (cocaine dependant) participants will receive two sessions of cocaine cue exposure (CCE), each separated by a 24 hr. period and both conducted while the participants remain in hospital. One group (PBO) will receive placebo following each CCE session while the second (40PP) and third (80PP) group will receive 40 mg and 80 mg propranolol, respectively. Participants will return two days, and 1, 3, and 6 weeks after discharge and will be administered a CCE session to assess for maintenance/generalization of disruption of reconsolidation (DoR) effects on craving and cue reactivity to familiar and novel cocaine cues. Participants will also be assessed 3 times weekly for cocaine use (self-report & urine drug screen) during follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Administered once orally following cue exposure on each of the first two days of testing. |
|
| Propranolol 40mg | Active Comparator | Administered once orally following cue exposure on each of the first two days of testing. |
|
| Propranolol, 80mg | Active Comparator | Administered once orally following cue exposure on each of the first two days of testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propranolol, 40 mg | Drug |
|
| |
| Propranolol, 80 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Use | Timeline of cocaine use throughout the duration of the study (in dollar amounts) | Evaluated at Weeks 1, 3 and 6 |
| Change in Craving Score | The participant is asked, "What is the level of craving you are experiencing on a scale or 0 to 100, with 0 representing no craving and 100 extreme craving"? | Single-Item Craving Scores are collected at all Retrieval Extinction Sessions (medication days), as well as all Phase Two Test Sessions (weeks 1,3 and 6). |
| Days of Abstinence | How many days the participants used cocaine versus how many days of abstinence they were able to achieve. | Week 1, Week 3, and Week 6 |
| Average Peak Craving Score | Peak Craving Response from Session Baseline- peak craving is measured by a scale with a score of 0 (no craving) -100 (maximum craving). | Day 2, Week 1, Week 3, and Week 6 |
| Use Days | Mean Days of Cocaine Use | Week 1, Week 3, Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael E Saladin, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Administered once orally following cue exposure on each of the first two days of testing. Placebo |
| FG001 | Propranolol 40mg | Administered once orally following cue exposure on each of the first two days of testing. Propranolol, 40 mg |
| FG002 | Propranolol, 80mg | Administered once orally following cue exposure on each of the first two days of testing. Propranolol, 80 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Administered once orally following cue exposure on each of the first two days of testing. Placebo |
| BG001 | Propranolol 40mg | Administered once orally following cue exposure on each of the first two days of testing. Propranolol, 40 mg |
| 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 | Cocaine Use | Timeline of cocaine use throughout the duration of the study (in dollar amounts) | Posted | Mean | Standard Error | Dollar amounts of cocaine use | Evaluated at Weeks 1, 3 and 6 |
|
Adverse events will be monitored throughout the study (six weeks) and all events will be followed to resolution or stabilization.
A serious adverse event is one that meets any of the following criteria:
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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 | Administered once orally following cue exposure on each of the first two days of testing. Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant Hospitalization | Psychiatric disorders | Non-systematic Assessment | Participant was hospitalized for depression and suicidal thoughts (no attempt). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Saladin | MUSC | 843-792-5306 | saladinm@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2018 | Oct 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
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| ID | Term |
|---|---|
| D011433 | Propranolol |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Drug |
|
|
| Placebo | Drug |
|
|
| BG002 | Propranolol, 80mg | Administered once orally following cue exposure on each of the first two days of testing. Propranolol, 80 mg |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Administered once orally following cue exposure on each of the first two days of testing.
Propranolol, 80 mg
|
|
| Primary | Change in Craving Score | The participant is asked, "What is the level of craving you are experiencing on a scale or 0 to 100, with 0 representing no craving and 100 extreme craving"? | Posted | Mean | Standard Error | score on a scale | Single-Item Craving Scores are collected at all Retrieval Extinction Sessions (medication days), as well as all Phase Two Test Sessions (weeks 1,3 and 6). |
|
|
|
| Primary | Days of Abstinence | How many days the participants used cocaine versus how many days of abstinence they were able to achieve. | Posted | Number | Days | Week 1, Week 3, and Week 6 |
|
|
|
| Primary | Average Peak Craving Score | Peak Craving Response from Session Baseline- peak craving is measured by a scale with a score of 0 (no craving) -100 (maximum craving). | Posted | Mean | Standard Error | score on a scale | Day 2, Week 1, Week 3, and Week 6 |
|
|
|
| Primary | Use Days | Mean Days of Cocaine Use | Posted | Mean | Standard Error | Days | Week 1, Week 3, Week 6 |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Propranolol 40mg | Administered once orally following cue exposure on each of the first two days of testing. Propranolol, 40 mg | 0 | 60 | 0 | 60 | 1 | 60 |
| EG002 | Propranolol, 80mg | Administered once orally following cue exposure on each of the first two days of testing. Propranolol, 80 mg | 0 | 62 | 0 | 62 | 0 | 62 |
|
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| D001519 |
| Behavior |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |
|
| Week 3 |
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| Week 6 |
|
| Title | Measurements |
|---|---|
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| Week 6 |
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| Week 3 |
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| Week 6 |
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| Week 6 |
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