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Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

Primary Purpose

Cocaine Dependent Subjects

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cocaine hydrochloride

propranolol

placebo

About this trial

This is an interventional basic science trial for Cocaine Dependent Subjects

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 - 50 years
voluntary, written, informed consent
physically healthy by medical history, physical, neurological, ECG, and laboratory examinations
DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
recent street cocaine use in excess of that administered in the current study
intravenous and/or smoked (crack/freebase) use
positive urine toxicology screen for cocaine
for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test
able to read English and complete study evaluations.

Exclusion Criteria:

Other drug dependence (except nicotine)
a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine
a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures)
current use of psychotropic and/or potentially psychoactive prescription medication
seeking treatment for drug abuse/dependence
those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG

Sites / Locations

Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

cocaine hydrochloride

propranolol

placebo

Arm Description

cocaine hydrochloride

propranolol

placebo

Outcomes

Primary Outcome Measures

Total number of patient controlled analgesic (PCA) pump activations (responses)

Data on cocaine self-administration (total number of responses) will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. Data that is not normally distributed will be log transformed. If it remains highly skewed after transformation, it will be analyzed using non-parametric approaches (e.g., a non-parametric, ANOVA-Type Statistic). Normally distributed data will be analyzed employing a mixed model design, 3-way ANOVA with co-factors of placebo vs propranolol (between subjects), non-cocaine predicting cues vs. cocaine predicting cues (within subjects) and non-reactivated cocaine cues vs. reactivated cocaine cues (within subjects).

Secondary Outcome Measures

Full Information

NCT ID

NCT01978457

First Posted

October 17, 2013

Last Updated

February 28, 2020

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT01978457

Brief Title

Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

Official Title

Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

Not funded

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2019 (Actual)

Study Completion Date

December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

4. Oversight

5. Study Description

Brief Summary

We will develop a procedure for conditioning cue-cocaine associations in human drug users. Next, we will reactivate that learning and intervene pharmacologically to prevent the reconsolidation of cue-drug memories. We hypothesize that a combined behavioral and pharmacological approach will have significant potential for persistently inhibiting relapse.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependent Subjects

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cocaine hydrochloride

Arm Type

Experimental

Arm Description

cocaine hydrochloride

Arm Title

propranolol

Arm Type

Experimental

Arm Description

propranolol

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

cocaine hydrochloride

Intervention Type

Drug

Intervention Name(s)

propranolol

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Total number of patient controlled analgesic (PCA) pump activations (responses)

Description

Time Frame

3 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 - 50 years voluntary, written, informed consent physically healthy by medical history, physical, neurological, ECG, and laboratory examinations DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20) recent street cocaine use in excess of that administered in the current study intravenous and/or smoked (crack/freebase) use positive urine toxicology screen for cocaine for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (-HCG) test able to read English and complete study evaluations. Exclusion Criteria: Other drug dependence (except nicotine) a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine a history of significant medical (cardiovascular) or neurological illness (e.g., prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrythmias of clinical significance, and/or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures) current use of psychotropic and/or potentially psychoactive prescription medication seeking treatment for drug abuse/dependence those having contraindications to beta-blocker administration, including diagnoses of asthma, bronchitis, emphysema, or a history of adverse reactions to beta-blockers (including propranolol), as well as those with bradycardia and/or first-degree or greater heart block by ECG

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

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Establishing and Eliminating Cue-drug Associations in Human Cocaine Addiction

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