Cocaine-Related DisorderNCT00580827
Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers
A study testing Disulfiram in people with Cocaine-Related Disorder and Opiate Dependence, run by Yale University at 1 site in United States.
Trial summary
This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine-Related Disorder, Opiate Dependence
- What is being tested?
- Disulfiram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Mar 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Between the ages of 18-65 years.
- Are not currently enrolled in treatment.
- Participants must demonstrate opioid dependence, as evidenced by documentation of prior opioid agonist maintenance and/or have signs of withdrawal upon administration of naloxone (<0.8 mg, i.m.), and an opioid-positive urine screen.
- Participants also must be current users of cocaine with self-reported use of > 7 gm during the preceding 12 months, self-reported use of > 1 time/week in at least one month preceding study entry, and cocaine-positive urine screen.
- Participants must fulfill DSM-IV criteria for opioid and cocaine dependence.
Who cannot join
- current diagnosis of other drug or alcohol physical dependence (other than opiates, cocaine or tobacco)
- significant medical conditions such as abnormal liver function (with laboratory findings greater than three times normal).
- active hepatitis; hypertension; a current cardiac condition or high risk of cardiovascular disease; seizure disorders; or another significant underlying medical condition which would contraindicate disulfiram or LAAM treatment.
- meets DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders; exhibiting current suicidality or homicidality; current use of a prescribed psychotropic medication that cannot be discontinued.
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to receive one of the following: placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or disulfiram at 250 mg/day. During induction onto LAAM, participants were administered increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus disulfiram or placebo disulfiram according to their randomized assignments, and were maintained on these agents through week 16. At the end of the study, participants underwent detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who received ongoing supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes included reductions in other illicit drug and alcohol use, as well as improvements in psychosocial functioning.
- Conditions
- Cocaine-Related Disorder, Opiate Dependence
- Being tested
- Placebo, Disulfiram
- 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.
PlaceboDrug
Matched placebo.
DisulfiramDrug
disulfiram at 62.5 mg/day for 12 weeks.
DisulfiramDrug
Disulfiram at 125 mg/day for 12 weeks.
DisulfiramDrug
disulfiram at 250 mg/day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| placebo disulfiram | Placebo comparator | placebo disulfiram (0 mg/day) Receives: Drug: Placebo |
| disulfiram 62.5 | Experimental | disulfiram at 62.5 mg/day Receives: Drug: Disulfiram |
| disulfiram 125 | Experimental | disulfiram at 125 mg/day Receives: Drug: Disulfiram |
| disulfiram 250 | Experimental | disulfiram at 250 mg/day Receives: Drug: Disulfiram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in cocaine use as measured by urine toxicology and self-report
Measured: 14 weeks
Secondary outcomes (1)
Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startSep 2003
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine-Related DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- James Poling, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580827
- Sponsor's protocol ID
- 9811010624
- Other IDs
- R01DA013441
- Status last verified
- Mar 2020
- First submitted
- 25 Dec 2007
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Traccis F, Minozzi S, Trogu E, Vacca R, Vecchi S, Pani PP, Agabio R. Disulfiram for the treatment of cocaine dependence. Cochrane Database Syst Rev. 2024 Jan 5;1(1):CD007024. doi: 10.1002/14651858.CD007024.pub3.
PubMed 38180268
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers
- ClinicalTrials.gov ID
- NCT00580827
- Acronym / sponsor ID
- 9811010624
- Conditions
- Cocaine-Related Disorder, Opiate Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 18-week, randomized, double blind clinical trial provided treatment for 160 cocaine-dependent opioid addicts, aged 18-65 years. Participants were stabilized on LAAM maintenance during the first 4 weeks and cocaine use was assessed; participants were then stratified by level of cocaine use and randomly assigned to receive one of the following: placebo disulfiram (0 mg/day), disulfiram at 62.5 mg/day, disulfiram at 125 mg/day, or disulfiram at 250 mg/day. During induction onto LAAM, participants were administered increasing doses of LAAM plus placebo disulfiram on a thrice-weekly basis until maintenance doses of LAAM are attained. At the beginning of week 5, participants received LAAM plus disulfiram or placebo disulfiram according to their randomized assignments, and were maintained on these agents through week 16. At the end of the study, participants underwent detoxification from LAAM and active/placebo medication over a 4- to 6-week period. All participants received weekly 1-hour psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically trained to deliver the therapy and who received ongoing supervision. The primary outcomes were retention and reduction in opioid and cocaine use, as assessed by self-report and confirmed by thrice-weekly urinalyses. Secondary outcomes included reductions in other illicit drug and alcohol use, as well as improvements in psychosocial functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo disulfiram | Placebo comparator | Drug: Placeboplacebo disulfiram (0 mg/day) |
| disulfiram 62.5 | Experimental | Drug: Disulfiramdisulfiram at 62.5 mg/day |
| disulfiram 125 | Experimental | Drug: Disulfiramdisulfiram at 125 mg/day |
| disulfiram 250 | Experimental | Drug: Disulfiramdisulfiram at 250 mg/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between the ages of 18-65 years.
- Are not currently enrolled in treatment.
- Participants must demonstrate opioid dependence, as evidenced by documentation of prior opioid agonist maintenance and/or have signs of withdrawal upon administration of naloxone (<0.8 mg, i.m.), and an opioid-positive urine screen.
- Participants also must be current users of cocaine with self-reported use of > 7 gm during the preceding 12 months, self-reported use of > 1 time/week in at least one month preceding study entry, and cocaine-positive urine screen.
- Participants must fulfill DSM-IV criteria for opioid and cocaine dependence.
Key exclusion criteria (5 listed)
- current diagnosis of other drug or alcohol physical dependence (other than opiates, cocaine or tobacco)
- significant medical conditions such as abnormal liver function (with laboratory findings greater than three times normal).
- active hepatitis; hypertension; a current cardiac condition or high risk of cardiovascular disease; seizure disorders; or another significant underlying medical condition which would contraindicate disulfiram or LAAM treatment.
- meets DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or other psychotic disorders; exhibiting current suicidality or homicidality; current use of a prescribed psychotropic medication that cannot be discontinued.
- pregnancy.
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 |
|---|---|---|
| PlaceboMatched placebo. | Drug | placebo disulfiram |
| Disulfiramdisulfiram at 62.5 mg/day for 12 weeks. | Drug | disulfiram 62.5 |
| DisulfiramDisulfiram at 125 mg/day for 12 weeks. | Drug | disulfiram 125 |
| Disulfiramdisulfiram at 250 mg/day for 12 weeks. | Drug | disulfiram 250 |
Primary outcome
Reductions in cocaine use as measured by urine toxicology and self-report
Time frame: 14 weeks
1 secondary outcome
Predictors of treatment efficacy using DBH genotyping for disulfiram will be tested.
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Derived from this study: PubMed 38180268Traccis F, Minozzi S, Trogu E, Vacca R, Vecchi S, Pani PP, Agabio R. Disulfiram for the treatment of cocaine dependence. Cochrane Database Syst Rev. 2024 Jan 5;1(1):CD007024. doi: 10.1002/14651858.CD007024.pub3.
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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.
James Poling, 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 Disulfiram in people with Cocaine-Related Disorder 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 5 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 31 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reductions in cocaine use as measured by urine toxicology and self-report (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580827, which also lists 1 linked publication.
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 31 Mar 2020.