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Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822587
Recruitment Status : Completed
First Posted : April 2, 2013
Results First Posted : December 17, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cocaine Addiction Drug: Propranolol, 40 mg Drug: Propranolol, 80 mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving, Reactivity and Use
Actual Study Start Date : September 2013
Actual Primary Completion Date : November 5, 2018
Actual Study Completion Date : November 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Administered once orally following cue exposure on each of the first two days of testing.
Drug: Placebo
Other Name: Sugar Pill

Active Comparator: Propranolol 40mg
Administered once orally following cue exposure on each of the first two days of testing.
Drug: Propranolol, 40 mg
Other Name: Inderal

Active Comparator: Propranolol, 80mg
Administered once orally following cue exposure on each of the first two days of testing.
Drug: Propranolol, 80 mg
Other Name: Inderal




Primary Outcome Measures :
  1. Cocaine Use [ Time Frame: Evaluated at Weeks 1, 3 and 6 ]
    Timeline of cocaine use throughout the duration of the study (in dollar amounts)

  2. Change in Craving Score [ 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). ]
    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"?

  3. Days of Abstinence [ Time Frame: Week 1, Week 3, and Week 6 ]
    How many days the participants used cocaine versus how many days of abstinence they were able to achieve.

  4. Average Peak Craving Score [ Time Frame: Day 2, Week 1, Week 3, and Week 6 ]
    Peak Craving Response from Session Baseline- peak craving is measured by a scale with a score of 0 (no craving) -100 (maximum craving).

  5. Use Days [ Time Frame: Week 1, Week 3, Week 6 ]
    Mean Days of Cocaine Use



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822587


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Michael E Saladin, PhD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01822587    
Other Study ID Numbers: 21392
First Posted: April 2, 2013    Key Record Dates
Results First Posted: December 17, 2019
Last Update Posted: December 26, 2019
Last Verified: December 2019
Keywords provided by Medical University of South Carolina:
Drug Abuse
Cocaine
Addiction
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents