Cocaine Dependence Clinical Trial
— CarvedilolOfficial title:
Cocaine Withdrawal and Pharmacotherapy Response
Verified date | March 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | January 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Veterans Hospital | West Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Days Abstinent From Cocaine - Self Report | Percent Self reported days of abstinence from any cocaine use during the 11 week trial. | 11 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04994821 -
tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study
|
Phase 2 | |
Completed |
NCT01601743 -
Exercise as a Behavioral Treatment for Cocaine Dependence
|
N/A | |
Completed |
NCT01402492 -
Cocaine Use Reduction With Buprenorphine
|
Phase 2/Phase 3 | |
Completed |
NCT01176591 -
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
|
Phase 2 | |
Completed |
NCT00880997 -
The Efficacy of Doxazosin for Cocaine Users
|
Phase 1 | |
Completed |
NCT00585520 -
Sex Differences in Progesterone Effects on Responses to Stress and Drug Cues
|
Phase 1 | |
Completed |
NCT00368290 -
Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior
|
Phase 2 | |
Completed |
NCT00385801 -
Study of the Effects of Risperdal Consta on Brain Reward Circuitry Function, Craving and Cocaine Use in Active Cocaine Dependence
|
Phase 2 | |
Completed |
NCT00322309 -
Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
|
Phase 2 | |
Completed |
NCT00842517 -
Long Term Maintenance of Drug Abstinence
|
Phase 1 | |
Completed |
NCT00167245 -
Topiramate for Alcohol and Cocaine Dependence
|
Phase 2 | |
Not yet recruiting |
NCT05974202 -
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
|
Phase 2 | |
Completed |
NCT04411914 -
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
|
Phase 1 | |
Active, not recruiting |
NCT03266939 -
Rebalancing the Serotonergic System in Cocaine Dependence
|
Phase 1 | |
Completed |
NCT02563769 -
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
|
Phase 1 | |
Recruiting |
NCT06159387 -
Randomized, Double-blind, Placebo-controlled Cannabis Extract x Placebo for Cocaine Addicts
|
Phase 4 | |
Terminated |
NCT02935101 -
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
|
Phase 2 | |
Completed |
NCT02018263 -
Validation of a Remote Wireless Sensor Network (WSN) Approach to the Individualized Detection of Cocaine Use in Humans
|
Phase 1 | |
Completed |
NCT01573273 -
Oxytocin in Cocaine Dependence
|
N/A | |
Withdrawn |
NCT01406522 -
Tacrine Effects on Cocaine Self-Administration and Pharmacokinetics
|
Phase 2 |