Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving
Primary Purpose
Cocaine Addiction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propranolol, 40 mg
Propranolol, 80 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Addiction focused on measuring Drug Abuse, Cocaine, Addiction
Eligibility Criteria
Inclusion Criteria:
- Participants must meet DSM-IV criteria for current cocaine dependence (within the past month). Participants may meet criteria for abuse, but not dependence, for any other substance with the exception of nicotine. Because of the high comorbidity of cocaine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment (nicotine patch will be provided to participants during the course of their involvement in the laboratory procedures). Although individuals who meet criteria for alcohol abuse will be accepted for study participation, anyone who has a measurable blood alcohol level on the day of testing will be excluded as acute alcohol intake can lower seizure threshold.
- Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.Exclusion Criteria:
- Use of one of the following methods of birth control by female participants: barrier methods (diaphragm or condoms with spermicidal or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
- Individuals must live within a 50-mile radius of our research program and have reliable transportation.
- Individuals must consent to remain abstinent from all drugs of abuse (except nicotine) for 72 hours immediately prior to CTRC inpatient admission.
- Individuals must consent to random assignment to one of three study groups (the two propranolol-treated groups or the placebo-treated group).
Exclusion Criteria:
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Individuals with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
- Individuals with significant liver impairment as propranolol is hepatically metabolized.
- Individuals with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
- Individuals currently taking anti-arrythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
- Known or suspected hypersensitivity to propranolol.
- Individuals taking medications that could adversely interact with the study medication, including, but not limited to albuterol, insulin, or significant inhibitors of CYP2D6.
- Individuals with bronchial asthma or chronic obstructive pulmonary disease, as the use of propranolol is contraindicated in these individuals.
- Individuals with any physical condition or disability that would compromise optimal sensory processing of the cues (e.g., blindness).
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Propranolol 40mg
Propranolol, 80mg
Arm Description
Administered once orally following cue exposure on each of the first two days of testing.
Administered once orally following cue exposure on each of the first two days of testing.
Administered once orally following cue exposure on each of the first two days of testing.
Outcomes
Primary Outcome Measures
Cocaine Use
Timeline of cocaine use throughout the duration of the study (in dollar amounts)
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"?
Days of Abstinence
How many days the participants used cocaine versus how many days of abstinence they were able to achieve.
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).
Use Days
Mean Days of Cocaine Use
Secondary Outcome Measures
Full Information
NCT ID
NCT01822587
First Posted
March 19, 2013
Last Updated
December 16, 2019
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01822587
Brief Title
Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving
Official Title
Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving, Reactivity and Use
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
November 5, 2018 (Actual)
Study Completion Date
November 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction
Keywords
Drug Abuse, Cocaine, Addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered once orally following cue exposure on each of the first two days of testing.
Arm Title
Propranolol 40mg
Arm Type
Active Comparator
Arm Description
Administered once orally following cue exposure on each of the first two days of testing.
Arm Title
Propranolol, 80mg
Arm Type
Active Comparator
Arm Description
Administered once orally following cue exposure on each of the first two days of testing.
Intervention Type
Drug
Intervention Name(s)
Propranolol, 40 mg
Other Intervention Name(s)
Inderal
Intervention Type
Drug
Intervention Name(s)
Propranolol, 80 mg
Other Intervention Name(s)
Inderal
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Primary Outcome Measure Information:
Title
Cocaine Use
Description
Timeline of cocaine use throughout the duration of the study (in dollar amounts)
Time Frame
Evaluated at Weeks 1, 3 and 6
Title
Change in Craving Score
Description
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"?
Time Frame
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).
Title
Days of Abstinence
Description
How many days the participants used cocaine versus how many days of abstinence they were able to achieve.
Time Frame
Week 1, Week 3, and Week 6
Title
Average Peak Craving Score
Description
Peak Craving Response from Session Baseline- peak craving is measured by a scale with a score of 0 (no craving) -100 (maximum craving).
Time Frame
Day 2, Week 1, Week 3, and Week 6
Title
Use Days
Description
Mean Days of Cocaine Use
Time Frame
Week 1, Week 3, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must meet DSM-IV criteria for current cocaine dependence (within the past month). Participants may meet criteria for abuse, but not dependence, for any other substance with the exception of nicotine. Because of the high comorbidity of cocaine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment (nicotine patch will be provided to participants during the course of their involvement in the laboratory procedures). Although individuals who meet criteria for alcohol abuse will be accepted for study participation, anyone who has a measurable blood alcohol level on the day of testing will be excluded as acute alcohol intake can lower seizure threshold.
Participants must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.Exclusion Criteria:
Use of one of the following methods of birth control by female participants: barrier methods (diaphragm or condoms with spermicidal or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse.
Individuals must live within a 50-mile radius of our research program and have reliable transportation.
Individuals must consent to remain abstinent from all drugs of abuse (except nicotine) for 72 hours immediately prior to CTRC inpatient admission.
Individuals must consent to random assignment to one of three study groups (the two propranolol-treated groups or the placebo-treated group).
Exclusion Criteria:
Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
Individuals with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes, as these conditions may affect heart rate or skin conductance measurement.
Individuals with significant liver impairment as propranolol is hepatically metabolized.
Individuals with a history of or current psychotic disorder, current major depressive disorder, bipolar affective disorder or a severe anxiety disorder as these may impact cue reactivity.
Individuals currently taking anti-arrythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
Known or suspected hypersensitivity to propranolol.
Individuals taking medications that could adversely interact with the study medication, including, but not limited to albuterol, insulin, or significant inhibitors of CYP2D6.
Individuals with bronchial asthma or chronic obstructive pulmonary disease, as the use of propranolol is contraindicated in these individuals.
Individuals with any physical condition or disability that would compromise optimal sensory processing of the cues (e.g., blindness).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Saladin, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
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Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving
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