Enhancing Disrupted Reconsolidation: Impact on Cocaine Craving

NCT01822587 | Completed Phase 2 Results DMC

• 1 other identifier: 21392
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Cocaine Addiction

Keywords

Drug Abuse; Cocaine; Addiction

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Administered once orally following cue exposure on each of the first two days of testing.

Drug: Placebo

Propranolol 40mg

ACTIVE COMPARATOR

Administered once orally following cue exposure on each of the first two days of testing.

Drug: Propranolol, 40 mg

Propranolol, 80mg

ACTIVE COMPARATOR

Administered once orally following cue exposure on each of the first two days of testing.

Drug: Propranolol, 80 mg

Interventions

Propranolol, 40 mg DRUG

Also known as: Inderal

Propranolol 40mg

Propranolol, 80 mg DRUG

Also known as: Inderal

Propranolol, 80mg

Placebo DRUG

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Substance-Related Disorders; Behavior, Addictive

Interventions

Propranolol; Sugars

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Michael Saladin
• Organization: MUSC

saladinm@musc.edu

843-792-5306

Study Officials

• Michael E Saladin, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: April 2, 2013
• Study Start: September 1, 2013
• Primary Completion: November 5, 2018
• Study Completion: November 5, 2018
• Last Updated: December 26, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-12

Locations

US (1)