Cocaine AbusePhase 1NCT00350870
CBT With Disulfiram and Contingency Management
A Phase 1 study testing disulfiram and Disulfiram plus Contingency Management in people with Cocaine Abuse, run by Yale University at 1 site in United States.
Trial summary
This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Abuse
- What is being tested?
- disulfiram and Disulfiram plus Contingency Management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2010
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-50 year old
- cocaine dependent
- willing to sign consent
- willing to accept randomization to intervention
Who cannot join
- significant medical conditions
- psychiatric disorder with current use of prescribed psychotropic medication
- lifetime schizophrenia or bipolar disorder
- suicidality or homicidality
- unlikely to be able to complete 1 year follow up
- unable to speak or read English at a third grade level
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).
Read the detailed description
This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatments:
- placebo
- disulfiram
- placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
- disulfiram plus incentives for cocaine abstinence and medication compliance
- Conditions
- Cocaine Abuse
- Being tested
- disulfiram, Placebo, Placebo plus Contingency Management, Disulfiram plus Contingency Management
- Keywords
- disulfiram, cognitive behavioral therapy, contingency management, drug abuse therapy, educational/resource design/development
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disulfiramDrug
Also called antabuse, antabus
250mg per day of Disulfiram plus CBT
PlaceboDrug
Placebo plus CBT
Placebo plus Contingency ManagementBehavioural
Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT
Disulfiram plus Contingency ManagementDrug
Also called antabuse, antabus
250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (plus Cognitive Behavioral Therapy- CBT) Receives: Drug: Placebo |
| Disulfiram | Active comparator | Disulfiram (plus CBT) Receives: Drug: disulfiram |
| Placebo plus Contingency Management | Placebo comparator | Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Receives: Behavioral: Placebo plus Contingency Management |
| Disulfiram plus Contingency Management | Active comparator | Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). Receives: Drug: Disulfiram plus Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cocaine Use by Self Report
Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.
Measured: 12 weeks
Change in Cocaine Use by Urine Toxicology Results
We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startApr 2005
- Primary completionDec 2010
- Study completionDec 2010
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cocaine AbuseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 181 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
- Kathleen M. Carroll, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350870
- Sponsor's protocol ID
- 0408026992
- Other IDs
- 5R01DA019078
- Status last verified
- Nov 2014
- First submitted
- 7 Jul 2006
- Last updated
- 3 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schick MR, Jaramillo Y, Kiluk BD, Nich C, LaPaglia D, Haeny AM. Testing measurement invariance of the Brief Symptom Inventory across race, sex, and time among adults with cocaine use disorder. Psychol Assess. 2026 Jul 9:10.1037/pas0001486. doi: 10.1037/pas0001486. Online ahead of print.
PubMed 42423707Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9.
PubMed 22775772Carroll KM, Nich C, Shi JM, Eagan D, Ball SA. Efficacy of disulfiram and Twelve Step Facilitation in cocaine-dependent individuals maintained on methadone: a randomized placebo-controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):224-31. doi: 10.1016/j.drugalcdep.2012.05.019. Epub 2012 Jun 12.
PubMed 22695473
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Efficacy of Cognitive Behavioral Therapy With Medication and Contingency Management
- ClinicalTrials.gov ID
- NCT00350870
- Acronym / sponsor ID
- 0408026992
- Conditions
- Cocaine Abuse
- Keywords
- disulfiram, cognitive behavioral therapy, contingency management, drug abuse therapy, educational/resource design/development
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Jul 2006 (estimated)
- Results
- Posted 3 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of four treatments for chronic cocaine use and may help study participants to control their drug use. All participants will receive weekly individual cognitive behavioral therapy (CBT).
Detailed description
This study will compare four types of treatment involving skills training and incentives for attending sessions or taking study medication. Disulfiram is a widely prescribed deterrent to alcohol use. In addition to weekly cognitive behavioral therapy (CBT), participants will be assigned to one of the following treatments:
- placebo
- disulfiram
- placebo plus incentives for cocaine abstinence and medication compliance (prize CM)
- disulfiram plus incentives for cocaine abstinence and medication compliance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (plus Cognitive Behavioral Therapy- CBT) |
| Disulfiram | Active comparator | Drug: disulfiramDisulfiram (plus CBT) |
| Placebo plus Contingency Management | Placebo comparator | Behavioral: Placebo plus Contingency ManagementPlacebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). |
| Disulfiram plus Contingency Management | Active comparator | Drug: Disulfiram plus Contingency ManagementDisulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-50 year old
- cocaine dependent
- willing to sign consent
- willing to accept randomization to intervention
Key exclusion criteria (6 listed)
- significant medical conditions
- psychiatric disorder with current use of prescribed psychotropic medication
- lifetime schizophrenia or bipolar disorder
- suicidality or homicidality
- unlikely to be able to complete 1 year follow up
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 |
|---|---|---|
| disulfiramAlso: antabuse, antabus250mg per day of Disulfiram plus CBT | Drug | Disulfiram |
| PlaceboPlacebo plus CBT | Drug | Placebo |
| Placebo plus Contingency ManagementPlacebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT | Behavioural | Placebo plus Contingency Management |
| Disulfiram plus Contingency ManagementAlso: antabuse, antabus250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT. | Drug | Disulfiram plus Contingency Management |
Primary outcome
Change in Cocaine Use by Self Report
Time frame: 12 weeks
Self-reports of substance use will be documented at each contact via the Substance Use Calendar. Similar to the Form-90 and the Time Line Follow-Back, which have been shown to be reliable and valid instruments for monitoring substance use and other outcomes in longitudinal studies202-204, the Substance Use Calendar allows a flexible, continuous evaluation of substance use on a daily basis.
Change in Cocaine Use by Urine Toxicology Results
Time frame: 12 weeks
We will use the Roche onsite TESTCUP system for detection of cocaine, methamphetamine, THC, benzodiazepenes, and opioids.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42423707Schick MR, Jaramillo Y, Kiluk BD, Nich C, LaPaglia D, Haeny AM. Testing measurement invariance of the Brief Symptom Inventory across race, sex, and time among adults with cocaine use disorder. Psychol Assess. 2026 Jul 9:10.1037/pas0001486. doi: 10.1037/pas0001486. Online ahead of print.
- Derived from this study: PubMed 22775772Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9.
- Derived from this study: PubMed 22695473Carroll KM, Nich C, Shi JM, Eagan D, Ball SA. Efficacy of disulfiram and Twelve Step Facilitation in cocaine-dependent individuals maintained on methadone: a randomized placebo-controlled trial. Drug Alcohol Depend. 2012 Nov 1;126(1-2):224-31. doi: 10.1016/j.drugalcdep.2012.05.019. Epub 2012 Jun 12.
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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.
Kathleen M. Carroll, PhD 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 Phase 1 study testing disulfiram and Disulfiram plus Contingency Management in people with Cocaine Abuse, 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 4 inclusion and 6 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 3 Dec 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2014). 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?
Change in Cocaine Use by Self Report (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00350870, which also lists 3 linked publications.
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 3 Dec 2014.