Cocaine DependencePhase 2NCT00218387
Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1
A Phase 2 study testing Modafinil in people with Cocaine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Modafinil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jul 2010
- Phase
- Phase 2
- 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
- Seeking treatment for cocaine dependence
- Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
- If female, willing to use effective contraception throughout the study
- Lives within 50 miles of the research center and has reliable transportation
Who cannot join
- Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
- Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
- Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
- Recent suicidal or homicidal attempts within 60 days of study entry
- Suicidal or homicidal ideation within 30 days of study entry
- Meets diagnosis criteria from the Differential Diagnosis of Psychotic Disorders section of Mini-SCID for a history of psychotic symptoms during a period of cocaine use (e.g., persistent hallucinations and delusions)
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- Serious medical illness, including left ventricular hypertrophy, mitral valve prolapse, left bundle branch block, heart attack, angina, serious liver disease (transaminase levels four times greater than normal), and kidney, neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
- Required by the court to obtain treatment for cocaine dependence
- Not seeking treatment for cocaine dependence
- Participated in cocaine treatment (clinical or research) within 30 days of study entry
- Anticipating elective surgery or hospitalization within 20 weeks of study entry
- Known or suspected hypersensitivity to modafinil
- Use of any of the following medications within 14 days of study entry: selective serotonin reuptake inhibitor antidepressants, tricyclic antidepressants, dopamine agonists, and other psychotropic medications, including anticonvulsants, antipsychotics, anxiolytics, or psychostimulants
- Currently taking medications that could adversely interact with study medications, including azole-type antifungals, cyclosporine, warfarin, theophylline, or carbamazepine
- Currently taking any medications that induce or inhibit CYP3A4 metabolic pathways
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: CBT and Modafinil for Cocaine Addiction
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.
Read the detailed description
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.
A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.
- Conditions
- Cocaine Dependence
- Being tested
- Modafinil, Matching Placebo
- Keywords
- Cocaine Dependence
- 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.
ModafinilDrug
Also called Provigil
200mg Modafinil
ModafinilDrug
Also called Provigil
400mg Modafinil
Matching PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| 200mg Modafinil | Experimental | 200mg Modafinil Receives: Drug: Modafinil |
| 400mg Modafinil | Experimental | 400mg Modafinil Receives: Drug: Modafinil |
| Matching Placebo | Placebo comparator | Matching Placebo Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cocaine Non-use Days
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Measured: 8 weeks
Percent of Participants With New Use
New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionJul 2010
- Study completionJul 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.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Malcolm, Medical University of South Carolina
- Investigators
- Robert Malcolm, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218387
- Sponsor's protocol ID
- NIDA-16368-1
- Other IDs
- R01DA016368, R01-16368-1, DPMC
- Status last verified
- Mar 2019
- First submitted
- 16 Sep 2005
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT and Modafinil for Cocaine Addiction
- ClinicalTrials.gov ID
- NCT00218387
- Acronym / sponsor ID
- NIDA-16368-1
- Conditions
- Cocaine Dependence
- Keywords
- Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2004
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Modafinil, a medication that enhances mood, increases energy, and improves concentration, may be useful in preventing relapse among individuals with cocaine addiction. This study will evaluate the effectiveness of modafinil, in combination with cognitive behavior therapy (CBT), to prevent drug relapse among cocaine addicts.
Detailed description
The development of a medication to treat cocaine addiction specifically by lessening withdrawal symptoms has been a primary focus of research. Common cocaine withdrawal symptoms include depression, lack of energy, and poor concentration. Modafinil, a central nervous system stimulant, is a medication that can speed up physical and mental processes in the brain. It is currently used to treat narcolepsy, a condition that causes excessive sleepiness. Modafinil enhances mood, increases energy, and improves concentration in people with narcolepsy. Modafinil may also cause the same effects in individuals addicted to cocaine, thereby countering the symptoms of cocaine withdrawal. The purpose of this study is to compare the effectiveness of modafinil plus CBT versus placebo plus CBT for treating cocaine dependence.
A 2-week screening period will be followed by an 8-week treatment phase. Participants will be randomly assigned to receive either 200 mg of modafinil, 400 mg of modafinil, or placebo on a daily basis for the 8 weeks of treatment. During this time, participants will be asked to report the number of days that they use and do not use cocaine. This will be confirmed three times a week with urine tests. Mood, level of daytime sleepiness, and symptoms of cocaine withdrawal and cocaine "high" will be evaluated. Compliance with study medication will be assessed with urine and blood tests. Medication side effects will be monitored through physical examinations, routine lab tests, ECGs, and self-reports. Follow-up evaluations will occur 4 and 8 weeks following the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200mg Modafinil | Experimental | Drug: Modafinil200mg Modafinil |
| 400mg Modafinil | Experimental | Drug: Modafinil400mg Modafinil |
| Matching Placebo | Placebo comparator | Drug: Matching PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Seeking treatment for cocaine dependence
- Meets DSM-IV diagnosis criteria for cocaine dependence as determined by Mini-SCID interview
- If female, willing to use effective contraception throughout the study
- Lives within 50 miles of the research center and has reliable transportation
Key exclusion criteria (16 listed)
- Meets DSM-IV/Mini-SCID diagnosis criteria for dependence on any drugs other than cocaine, alcohol, nicotine, or marijuana
- Physiologic dependence on alcohol requiring medical detoxification, on either an inpatient or outpatient basis
- Current psychiatric disorder, including depression, schizophrenia, bipolar affective disorder, organic brain disease, dementia, or other types of psychosis
- Recent suicidal or homicidal attempts within 60 days of study entry
- Suicidal or homicidal ideation within 30 days of study entry
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 |
|---|---|---|
| ModafinilAlso: Provigil200mg Modafinil | Drug | 200mg Modafinil |
| ModafinilAlso: Provigil400mg Modafinil | Drug | 400mg Modafinil |
| Matching PlaceboMatching Placebo | Drug | Matching Placebo |
Primary outcome
Number of Cocaine Non-use Days
Time frame: 8 weeks
Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Percent of Participants With New Use
Time frame: 8 weeks
New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Malcolm, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modafinil in people with Cocaine Dependence, run by Medical University of South Carolina 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 16 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 10 Apr 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 10 Apr 2019). 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?
Number of Cocaine Non-use Days (time frame: 8 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?
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 10 Apr 2019.