Cocaine-Related DisordersPhase 2NCT00218062
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
A Phase 2 study testing D-Amphetamine 30mg, D-Amphetamine 60mg and Modafinil 200mg in people with Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- D-Amphetamine 30mg, D-Amphetamine 60mg and Modafinil 200mg
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV (SCID) criteria for cocaine abuse or dependence
- In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.
Who cannot join
- Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine
- Current cardiovascular disease, as determined by an electrocardiogram
- On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
- Previously received treatment with d-amphetamine, modafinil, or aripiprazole
- Currently receiving prescribed medication
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 (Cocaine Dependence Population)
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.
Read the detailed description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.
This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.
- Conditions
- Cocaine-Related Disorders
- Being tested
- D-Amphetamine 30mg, D-Amphetamine 60mg, Modafinil 200mg, Modafinil 400mg, Therapy
- 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.
D-Amphetamine 30mgDrug
D-Amphetamine 60mgDrug
Modafinil 200mgDrug
Modafinil 400mgDrug
TherapyBehavioural
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| D-Amphetamine 60mg + Therapy | Experimental | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. Receives: Drug: D-Amphetamine 60mg; Behavioral: Therapy |
| Modafinil 400mg + Therapy | Experimental | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. Receives: Drug: Modafinil 400mg; Behavioral: Therapy |
| Modafinil 200mg + D-Amphetamine 30mg + Therapy | Experimental | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. Receives: Drug: D-Amphetamine 30mg; Drug: Modafinil 200mg; Behavioral: Therapy |
| Placebo + Therapy | Placebo comparator | During the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance.
Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. Receives: Behavioral: Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
Measured: 16 weeks
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
Measured: 16 weeks
Retention as Indicated by the Number of Participants Who Remained in the Study
Measured: 16 weeks
Secondary outcomes (2)
Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
Measured: 16 weeks
Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
Measured: 16 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 startMar 2006
- Primary completionJan 2012
- Study completionJan 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine-Related DisordersStudies 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
- 73 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Joy Schmitz, The University of Texas Health Science Center, Houston
- Investigators
- Joy M. Schmitz, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218062
- Sponsor's protocol ID
- NIDA-09262-12
- Other IDs
- P50DA009262-12, DPMC
- Status last verified
- May 2017
- First submitted
- 16 Sep 2005
- Last updated
- 21 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation. Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012.
PubMed 22969732
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacotherapy Dosing Regimen (Cocaine Dependence Population)
- ClinicalTrials.gov ID
- NCT00218062
- Acronym / sponsor ID
- NIDA-09262-12
- Conditions
- Cocaine-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Posted 21 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to examine the effects of d-amphetamine and modafinil, when given alone and in combination, in treating cocaine dependent individuals.
Detailed description
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central nervous system stimulant that is approved to treat individuals with narcolepsy and attention deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine dependence. The purpose of this study is to examine the effectiveness of modafinil and d-amphetamine, alone and in combination, in treating cocaine dependent individuals.
This study will last 16 weeks. Participants will be randomly assigned to one of four groups: 1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg of modafinil over 4 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| D-Amphetamine 60mg + Therapy | Experimental | Drug: D-Amphetamine 60mg, Behavioral: TherapyDuring the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. d-Amphetamine sustained release (SR) (Dexedrine Spansules) started at 15 mg (day 1-2), increased to 30mg (day3; 15mg, BID), 45mg (day4; 15mg, TID), and 60mg (day5; 15mg bid plus 30mg qd). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| Modafinil 400mg + Therapy | Experimental | Drug: Modafinil 400mg, Behavioral: TherapyDuring the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. Modafinil started at 200mg (day1) and increased to 400mg (days2-5). A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| Modafinil 200mg + D-Amphetamine 30mg + Therapy | Experimental | Drug: D-Amphetamine 30mg, Drug: Modafinil 200mg, Behavioral: TherapyDuring the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Medication administration was initiated during a 5 day run-up period. For the combination condition, dosages of modafinil and d-amphetamine were escalated to one-half of that for the single medication conditions. A 5-day dose reduction schedule occurred at week 17. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
| Placebo + Therapy | Placebo comparator | Behavioral: Therapy, Drug: PlaceboDuring the 16 weeks of outpatient treatment, participants took three capsules daily (two in the morning, one in the afternoon). All active and placebo capsules were identical in appearance and each contained 50mg riboflavin for subsequent evaluation of medication compliance. Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meets Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-IV (SCID) criteria for cocaine abuse or dependence
- In general good health. Individuals who are HIV-positive will not be excluded if in good general health, unless medication interactions exist.
Key exclusion criteria (5 listed)
- Meets diagnostic criteria for psychiatric disorders, including other forms of drug dependence, other than nicotine
- Current cardiovascular disease, as determined by an electrocardiogram
- On probation or parole if the circumstances do not allow study completion or if ethical constraints of supervision do not allow confidentiality
- Previously received treatment with d-amphetamine, modafinil, or aripiprazole
- Currently receiving prescribed medication
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 |
|---|---|---|
| D-Amphetamine 30mg | Drug | Modafinil 200mg + D-Amphetamine 30mg + Therapy |
| D-Amphetamine 60mg | Drug | D-Amphetamine 60mg + Therapy |
| Modafinil 200mg | Drug | Modafinil 200mg + D-Amphetamine 30mg + Therapy |
| Modafinil 400mg | Drug | Modafinil 400mg + Therapy |
| TherapyManual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills. | Behavioural | D-Amphetamine 60mg + Therapy, Modafinil 200mg + D-Amphetamine 30mg + Therapy, Modafinil 400mg + Therapy, Placebo + Therapy |
| Placebo | Drug | Placebo + Therapy |
Primary outcome
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment
Time frame: 16 weeks
Retention as Indicated by the Number of Participants Who Completed 16 Weeks of Treatment
Time frame: 16 weeks
Retention as Indicated by the Number of Participants Who Remained in the Study
Time frame: 16 weeks
2 secondary outcomes
Medication Compliance as Indicated by Percentage of Pills Taken According to Self-report
Time frame: 16 weeks
Medication Compliance as Indicated by Percentage of Riboflavin-positive Urine Samples
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22969732Schmitz JM, Rathnayaka N, Green CE, Moeller FG, Dougherty AE, Grabowski J. Combination of Modafinil and d-amphetamine for the Treatment of Cocaine Dependence: A Preliminary Investigation. Front Psychiatry. 2012 Aug 30;3:77. doi: 10.3389/fpsyt.2012.00077. eCollection 2012.
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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
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 D-Amphetamine 30mg, D-Amphetamine 60mg and Modafinil 200mg in people with Cocaine-Related Disorders, 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 2 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 21 Jun 2017. 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 21 Jun 2017). 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?
Cocaine Use as Assessed by the Treatment Effectiveness Score (TES), Which is the Total Number of Cocaine-negative Urines During Treatment (time frame: 16 weeks). The study lists 3 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 NCT00218062, 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 21 Jun 2017; AzTrials last refreshed its copy on 7 Nov 2026.