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Cocaine Withdrawal and Pharmacotherapy Response (Carvedilol)

Primary Purpose

Cocaine Dependence, Opiate Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sugar pill
Carvedilol 25 mg
Carvedilol 50 mg
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cocaine Dependence focused on measuring cocaine, opiate, methadone, carvedilol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Current opioid dependence as evidenced by documented prior treatment for opioid dependence or signs of opiate withdrawals, self-reported history of opioid dependence for a consecutive 12 month period and a positive urine for opiates.
  • Current cocaine use with self-reported use of cocaine > 1 time/week in at least on month preceding study entry, provision of a cocaine-positive urine and fulfilled DSM-IV criteria for cocaine dependence
  • For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests.

Exclusion Criteria:

  • current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco);
  • serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, hepatic disorders;
  • current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts;
  • screening liver function tests (AST or ALT) greater than 3 times normal;
  • known allergy or intolerance for carvedilol or methadone.

Sites / Locations

  • Veterans Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Sugar Pill

Carvedilol 25 mg

Carvedilol 50 mg

Arm Description

To be compared to active drug

To be compared to placebo and Carvedilol 50 mg

To be compared to placebo and Carvedilol 25 mg

Outcomes

Primary Outcome Measures

Percent Days Abstinent From Cocaine - Self Report
Percent Self reported days of abstinence from any cocaine use during the 11 week trial.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2007
Last Updated
March 31, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00566969
Brief Title
Cocaine Withdrawal and Pharmacotherapy Response
Acronym
Carvedilol
Official Title
Cocaine Withdrawal and Pharmacotherapy Response
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A total of 120 male and female opioid dependent cocaine users will participate in this study. This study will be a 8-week double-blind, placebo controlled study examining the dose-dependent effects of carvedilol (up to 50 mg/day) in methadone stabilized patients. The design will have two phases: 1) a four-week "treatment " phase; and 2) a 4 week " taper and detoxification or transfer" phase. Subjects will be cocaine users who are on stable doses of methadone (60 to 140 mg/day). Carvedilol dose will be increased from 12.5mg/day to the target dose of either 25 or 50 mg/day as tolerated. At the end of the treatment-phase, subjects will undergo detoxification from methadone over a 2 to 4-week period based on an individual's needs, and they will concurrently be tapered off carvedilol.
Detailed Description
The adrenergic neurotransmission serves multiple functions including learning, emotional processing and stress response to psychological and physical challenges (Huether, 1996; Sved et al., 2001). Adrenergic transmission also mediates drug withdrawal states and stress-induced relapse to drug use (Aston-Jones et al., 2004; Stewart, 2000). Consistent with these preclinical findings, adrenergic blockers showed promise as a treatment of cocaine dependence (Kampman et al., 2001b; Kampman et al., 2006). These preliminary findings are significant because there are no proven pharmacotherapies for cocaine addiction although an estimated 2.3 million of Americans aged 12 or older are regular cocaine users (SAMHSA, 2004). The societal cost of cocaine addiction is estimated to be $45 billion in the US, suggesting that development of even modestly effective cocaine pharmacotherapies will have great economic benefits. For example, availability of a medication decreasing cocaine use by 10 percent is estimated to have $745 million economic benefit in the US alone (Cartwright, 2000). Thus, developing effective treatments for cocaine addiction is an essential goal with significant benefits both for the society and the individual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Opiate Dependence
Keywords
cocaine, opiate, methadone, carvedilol

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
To be compared to active drug
Arm Title
Carvedilol 25 mg
Arm Type
Active Comparator
Arm Description
To be compared to placebo and Carvedilol 50 mg
Arm Title
Carvedilol 50 mg
Arm Type
Active Comparator
Arm Description
To be compared to placebo and Carvedilol 25 mg
Intervention Type
Drug
Intervention Name(s)
sugar pill
Other Intervention Name(s)
placebo
Intervention Description
Subjects randomized to placebo, carvedilol 25mg or 50mg
Intervention Type
Drug
Intervention Name(s)
Carvedilol 25 mg
Other Intervention Name(s)
Coreg
Intervention Description
subjects randomized to placebo, carvedilol 25mg or 50mg
Intervention Type
Drug
Intervention Name(s)
Carvedilol 50 mg
Other Intervention Name(s)
Coreg
Intervention Description
subjects randomized to placebo, carvedilol 25mg or 50mg
Primary Outcome Measure Information:
Title
Percent Days Abstinent From Cocaine - Self Report
Description
Percent Self reported days of abstinence from any cocaine use during the 11 week trial.
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current opioid dependence as evidenced by documented prior treatment for opioid dependence or signs of opiate withdrawals, self-reported history of opioid dependence for a consecutive 12 month period and a positive urine for opiates. Current cocaine use with self-reported use of cocaine > 1 time/week in at least on month preceding study entry, provision of a cocaine-positive urine and fulfilled DSM-IV criteria for cocaine dependence For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests. Exclusion Criteria: current diagnosis of other drug or alcohol dependence (other than opiates, cocaine or tobacco); serious medical illness including asthma, diabetes, bradycardia, or other arrhythmias and major cardiovascular, renal, endocrine, hepatic disorders; current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts; screening liver function tests (AST or ALT) greater than 3 times normal; known allergy or intolerance for carvedilol or methadone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, M.D., Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Hospital
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cocaine Withdrawal and Pharmacotherapy Response

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