Cocaine AbusePhase 2NCT00218036
Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8
A Phase 2 study testing Modafinil 200mg, Modafinil 400mg and Citalopram 20mg in people with Cocaine Abuse and Opiate Dependence, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Abuse, Opiate Dependence
- What is being tested?
- Modafinil 200mg, Modafinil 400mg and Citalopram 20mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 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 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets cocaine abuse and dependence criteria (as determined by the SCID)
- Meets opiate dependence criteria (as determined by the SCID)
- In good general physical and psychiatric health (except for possible acute drug use related problems)
Who cannot join
- Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)
- Current cardiovascular disease (as determined by an electrocardiogram)
- Circumstances will not allow for completion of study (on probation or parole)
- Ethical constraints of supervision do not allow confidentiality (on probation or parole)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
Houston, Texas, 77030
About this study
Official title: Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.
Read the detailed description
This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.
Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.
- Conditions
- Cocaine Abuse, Opiate Dependence
- Being tested
- Modafinil 200mg, Modafinil 400mg, Citalopram 20mg, Citalopram 40mg, Placebo
- Keywords
- Cocaine Abuse, Opiate Abuse
- 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.
Modafinil 200mgDrug
10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
Modafinil 400mgDrug
10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
Citalopram 20mgDrug
10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days.
Citalopram 40mgDrug
10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days.
PlaceboDrug
Placebo while patient is methadone maintained on standard dose of 1.2 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Modafinil 200mg / Methadone Maintenance (1.2mg/kg) Receives: Drug: Modafinil 200mg |
| 2 | Experimental | Modafinil 400mg/ Methadone Maintenance (1.2mg/kg) Receives: Drug: Modafinil 400mg |
| 3 | Experimental | Citalopram 20/ Methadone Maintenance 1.2mg/kg Receives: Drug: Citalopram 20mg |
| 4 | Experimental | Citalopram 40/ Methadone Maintenance 1.2 mg/kg Receives: Drug: Citalopram 40mg |
| 5 | Placebo comparator | Placebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Abstinence From Cocaine
Measured: 12 weeks of treatment
Secondary outcomes (2)
Retention
Measured: 12 weeks of treatment
Medication Compliance
Measured: 12 weeks of treatment
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 startJul 2006
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: PI left institution, end of funding, clinic relocation, recruitment issues
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 AbuseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Texas
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
- Investigators
- Joy M Schmitz, PhD, Principal investigator, University of TexasF. Gerard Moeller, M.D., Study chair, University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218036
- Sponsor's protocol ID
- NIDA-09262-8
- Other IDs
- P50DA009262-08, DPMC
- Status last verified
- Oct 2018
- First submitted
- 16 Sep 2005
- Last updated
- 16 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals
- ClinicalTrials.gov ID
- NCT00218036
- Acronym / sponsor ID
- NIDA-09262-8
- Conditions
- Cocaine Abuse, Opiate Dependence
- Keywords
- Cocaine Abuse, Opiate Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution, end of funding, clinic relocation, recruitment issues
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Texas
- Study start
- Jul 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 16 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine two medications, modafinil and citalopram, in the treatment of cocaine dependent individuals who are maintained on methadone.
Detailed description
This is a 24-week, randomized, double-blind, placebo-controlled study examining two doses of modafinil (200 and 400 mg) and citalopram (20 and 40 mg) in the treatment of methadone maintained cocaine dependent individuals.
Participants will first be given methadone to determine its tolerated and effective doses. Most participants will be able to reach a stable dose of methadone within 7 to 10 days of methadone initiation. When 80% of the projected dose of methadone has been achieved, participants will begin the medication regimen of modafinil or citalopram. Modafinil will be given over a 7-day period. Dosing of modafinil will begin at 200 mg and, depending on the individual, may increase to 400 mg. Citalopram will be given in increasing doses, starting at 20 mg and increasing to 40mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Modafinil 200mgModafinil 200mg / Methadone Maintenance (1.2mg/kg) |
| 2 | Experimental | Drug: Modafinil 400mgModafinil 400mg/ Methadone Maintenance (1.2mg/kg) |
| 3 | Experimental | Drug: Citalopram 20mgCitalopram 20/ Methadone Maintenance 1.2mg/kg |
| 4 | Experimental | Drug: Citalopram 40mgCitalopram 40/ Methadone Maintenance 1.2 mg/kg |
| 5 | Placebo comparator | Drug: PlaceboPlacebo given to methadone-maintained subjects (1.2mg/kg) for the duration of the 12-week study |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets cocaine abuse and dependence criteria (as determined by the SCID)
- Meets opiate dependence criteria (as determined by the SCID)
- In good general physical and psychiatric health (except for possible acute drug use related problems)
Key exclusion criteria (4 listed)
- Meets diagnostic criteria for other psychiatric disorders, including other forms of drug dependence (other than nicotine)
- Current cardiovascular disease (as determined by an electrocardiogram)
- Circumstances will not allow for completion of study (on probation or parole)
- Ethical constraints of supervision do not allow confidentiality (on probation or parole)
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 |
|---|---|---|
| Modafinil 200mg10 day medication run-up to Modafinil 200mg while subject is methadone maintained at 1/2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days. | Drug | 1 |
| Modafinil 400mg10 day medication run-up to 400mg of Modafinil while subject is methadone maintained at 1.2 mg/kg. On full dose for 12 weeks and then titrated down for 10 days. | Drug | 2 |
| Citalopram 20mg10 day run-up to Citalopram 20mg while subject is methadone maintained at 1.2mg/kg. On full dose for 12 weeks and then titrated down for 10 days. | Drug | 3 |
| Citalopram 40mg10 day medication run-up to Citalopram 40 mg while subjects are methadone maintained (1.2 mg/kg). On full dose for 12 weeks and then titrated down for 10 days. | Drug | 4 |
| PlaceboPlacebo while patient is methadone maintained on standard dose of 1.2 mg/kg | Drug | 5 |
Primary outcome
Confirmed Abstinence From Cocaine
Time frame: 12 weeks of treatment
2 secondary outcomes
Retention
Time frame: 12 weeks of treatment
Medication Compliance
Time frame: 12 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- 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.
Joy M Schmitz, PhD principal investigator
University of Texas
F. Gerard Moeller, M.D. study chair
University of Texas Medical School at Houston
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 200mg, Modafinil 400mg and Citalopram 20mg in people with Cocaine Abuse and Opiate Dependence, run by The University of Texas Health Science Center, Houston 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 4 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: stopped early, as of the sponsor's last update on 16 Nov 2018. 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 16 Nov 2018). 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?
Confirmed Abstinence From Cocaine (time frame: 12 weeks of treatment). 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 16 Nov 2018.