Attention Deficit Disorder With HyperactivityPhase 2NCT00514202
Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)
A Phase 2 study testing Dextroamphetamine SR in people with Attention Deficit Disorder With Hyperactivity and Cocaine-Related Disorders, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders, Substance-Related Disorders
- What is being tested?
- Dextroamphetamine SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Oct 2008
- Phase
- Phase 2
- 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
- Provide informed consent
- Generally good health except for problems related to drug use
- Meet DSM criteria for cocaine dependence and ADHD
- Have stable living situation
Who cannot join
- DSM diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine)
- Current use of prescription medications
- Females who are currently pregnant or nursing
- History of significant acute or chronic physical illness
- History of or current liver disease
- Existing cardiovascular disease
- Plans to leave metropolitan area within 3 months
- Probation or parole with constraints that preclude full study participation
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: Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD
Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD.
Read the detailed description
This double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and ADHD. Participants will be randomly assigned on receive placebo or Dextroamphetamine SR (60 mg/day) during a 12-week study period. All participants will receive weekly cognitive behavioral therapy.
- Conditions
- Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders, Substance-Related Disorders
- Being tested
- Placebo, Dextroamphetamine SR
- Keywords
- cocaine, ADHD, attention, hyperactivity, drug, dependence
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Cocaine-Related Disorders, Substance-Related Disorders, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
matched placebo
Dextroamphetamine SRDrug
Also called Dexedrine Spansules
60 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo plus cognitive behavioral therapy Receives: Drug: Placebo |
| 2 | Experimental | Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy Receives: Drug: Dextroamphetamine SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
Measured: Duration of study
ADHD symptoms
Measured: Duration of study
Secondary outcomes (2)
Treatment retention
Measured: Duration of study
Cocaine craving
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Investigator left UTHSC-Houston
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David V Herin, Ph.D, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514202
- Sponsor's protocol ID
- HSC-MS-07-0024
- Other IDs
- P50DA009262
- Status last verified
- Feb 2012
- First submitted
- 7 Aug 2007
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD
- ClinicalTrials.gov ID
- NCT00514202
- Acronym / sponsor ID
- HSC-MS-07-0024
- Conditions
- Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders, Substance-Related Disorders
- Keywords
- cocaine, ADHD, attention, hyperactivity, drug, dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left UTHSC-Houston
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Aug 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.
Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD.
Detailed description
This double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and ADHD. Participants will be randomly assigned on receive placebo or Dextroamphetamine SR (60 mg/day) during a 12-week study period. All participants will receive weekly cognitive behavioral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo plus cognitive behavioral therapy |
| 2 | Experimental | Drug: Dextroamphetamine SRDextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provide informed consent
- Generally good health except for problems related to drug use
- Meet DSM criteria for cocaine dependence and ADHD
- Have stable living situation
Key exclusion criteria (8 listed)
- DSM diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine)
- Current use of prescription medications
- Females who are currently pregnant or nursing
- History of significant acute or chronic physical illness
- History of or current liver disease
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 | 1 |
| Dextroamphetamine SRAlso: Dexedrine Spansules60 mg/day | Drug | 2 |
Primary outcome
Substance use
Time frame: Duration of study
ADHD symptoms
Time frame: Duration of study
2 secondary outcomes
Treatment retention
Time frame: Duration of study
Cocaine craving
Time frame: Duration of study
Results and safety
The study was stopped early (reason given: Investigator left UTHSC-Houston). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
Related trials for Attention Deficit Disorder With Hyperactivity
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 2
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
Attention Deficit Disorder With Hyperactivity (ADHD)
RecruitingObservational study
Pharmacogenomics of Stimulant Treatment Response
Attention-Deficit/ Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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.
David V Herin, Ph.D principal investigator
The University of Texas Health Science Center, 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 Dextroamphetamine SR in people with Attention Deficit Disorder With Hyperactivity and 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 4 inclusion and 8 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 22 Feb 2012. 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?
The study was stopped early (reason given: Investigator left UTHSC-Houston). Results are not available in the source record.
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?
Substance use (time frame: Duration of study). 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 22 Feb 2012.