Cocaine DependenceCarvedilolNCT00566969
Cocaine Withdrawal and Pharmacotherapy Response
A study testing sugar pill, Carvedilol 25 mg and Carvedilol 50 mg in people with Cocaine Dependence and Opiate Dependence, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence, Opiate Dependence
- What is being tested?
- sugar pill, Carvedilol 25 mg and Carvedilol 50 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cocaine Dependence, Opiate Dependence
- Being tested
- sugar pill, Carvedilol 25 mg, Carvedilol 50 mg
- Keywords
- cocaine, opiate, methadone, carvedilol
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar pillDrug
Also called placebo
Subjects randomized to placebo, carvedilol 25mg or 50mg
Carvedilol 25 mgDrug
Also called Coreg
subjects randomized to placebo, carvedilol 25mg or 50mg
Carvedilol 50 mgDrug
Also called Coreg
subjects randomized to placebo, carvedilol 25mg or 50mg
| Study group | Role | What they receive |
|---|---|---|
| Sugar Pill | Placebo comparator | To be compared to active drug Receives: Drug: sugar pill |
| Carvedilol 25 mg | Active comparator | To be compared to placebo and Carvedilol 50 mg Receives: Drug: Carvedilol 25 mg |
| Carvedilol 50 mg | Active comparator | To be compared to placebo and Carvedilol 25 mg Receives: Drug: Carvedilol 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Days Abstinent From Cocaine - Self Report
Percent Self reported days of abstinence from any cocaine use during the 11 week trial.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Mehmet Sofuoglu, M.D., Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566969
- Sponsor's protocol ID
- 0704002562
- Other IDs
- R01DA014537, DPMC
- Acronym
- Carvedilol
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2007
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cocaine Withdrawal and Pharmacotherapy Response
- ClinicalTrials.gov ID
- NCT00566969
- Acronym / sponsor ID
- Carvedilol / 0704002562
- Conditions
- Cocaine Dependence, Opiate Dependence
- Keywords
- cocaine, opiate, methadone, carvedilol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Dec 2007 (estimated)
- Results
- Posted 10 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar Pill | Placebo comparator | Drug: sugar pillTo be compared to active drug |
| Carvedilol 25 mg | Active comparator | Drug: Carvedilol 25 mgTo be compared to placebo and Carvedilol 50 mg |
| Carvedilol 50 mg | Active comparator | Drug: Carvedilol 50 mgTo be compared to placebo and Carvedilol 25 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sugar pillAlso: placeboSubjects randomized to placebo, carvedilol 25mg or 50mg | Drug | Sugar Pill |
| Carvedilol 25 mgAlso: Coregsubjects randomized to placebo, carvedilol 25mg or 50mg | Drug | Carvedilol 25 mg |
| Carvedilol 50 mgAlso: Coregsubjects randomized to placebo, carvedilol 25mg or 50mg | Drug | Carvedilol 50 mg |
Primary outcome
Percent Days Abstinent From Cocaine - Self Report
Time frame: 11 weeks
Percent Self reported days of abstinence from any cocaine use during the 11 week trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Sofuoglu, M.D., Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugar pill, Carvedilol 25 mg and Carvedilol 50 mg in people with Cocaine Dependence and Opiate Dependence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Days Abstinent From Cocaine - Self Report (time frame: 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.