Attention Deficit Disorder With HyperactivityPhase 2NCT00142961
Atomoxetine for Treating Marijuana-Abusing Adolescents Who Have Attention Deficit Hyperactivity Disorder
A Phase 2 study testing Atomoxetine in people with Attention Deficit Disorder With Hyperactivity and Marijuana Abuse, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Marijuana Abuse
- What is being tested?
- Atomoxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jan 2007
- 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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets DSM-IV criteria for marijuana dependence and reports that marijuana is their primary drug of abuse
- Meets DSM-IV criteria for ADHD, as determined by the CAADID
- Females will be included if not pregnant or breastfeeding, and agree to use an adequate method of contraception for the duration of the study
Who cannot join
- Meets DSM-IV criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, current major depression, bipolar illness, or psychiatric disorders (individuals with substance-induced mood disorder with depressive features as well as substance induced anxiety disorder will not be excluded from the study)
- Medically unstable (based on laboratory tests, an electrocardiogram, medical history, and physical examination) such that study participation would be hazardous; examples include uncontrolled high blood pressure and faster than normal heart rate (systolic blood pressure greater than 130, diastolic blood pressure greater than 80, or a resting heart rate greater than 90) or diabetes
- History of seizures
- Current suicidal risk
- Pregnant or breastfeeding
- Physiologically dependent on any other drugs (excluding nicotine) that requires a medical intervention
Show all 16Show fewer
- Known sensitivity to atomoxetine
- Prior treatment failure with atomoxetine
- Currently receiving effective treatment with atomoxetine
- Coronary vascular disease, as indicated by a history or suspected by an abnormal ECG or history of cardiac symptoms
- Currently taking a psychotropic medication
- Currently taking cough medicine (e.g., dextromethorphan) or albuterol
- Currently taking or history of taking monoamine oxidase inhibitors (MAOIs) within 2 weeks prior to enrollment
- Narrow angle glaucoma
- Hepatitis
- Adolescents who are prisoners as defined by OHRP regulations, namely directly court-mandated adolescents (as opposed to probation or parole-mandated clients, as well as voluntary clients, who will not be excluded)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Marijuana-Abusing Attention Deficit Hyperactivity Disorder (ADHD) Teens: Atomoxetine Treatment
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
Read the detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. Therefore, it is important to develop treatments targeting adolescents diagnosed with both ADHD and marijuana dependence. Atomoxetine is currently used to treat individuals diagnosed with ADHD. The purpose of this study is to determine the feasibility of administering atomoxetine in a therapeutic setting to adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms. Finally, this study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo. Study visits will occur 2 times each week for the duration of the 12-week trial. At each study visit, vital signs and medication side effects will be assessed. In addition, psychiatric ratings measurements will be evaluated. Participants will also complete self reports in order to track ADHD-related symptoms. Starting at the Week 2 study visit, all participants will receive psychotherapy sessions. This will involve cognitive-behavioral therapy/relapse prevention treatment that has been designed specifically for ADHD adolescents. The aim of the cognitive skills training will be to assist the participants in developing the skills necessary to manage their drug use as well as the symptoms they experience related to ADHD. At Month 6, a follow-up visit will occur, at which time participants urine toxicology tests will be completed to determine if participants have been using marijuana or any other substances of abuse. In addition, at the Month 6 follow-up visit, participants will complete psychiatric ratings, self reports, and will meet with a physician to assess ADHD-related symptoms.
- Being tested
- Atomoxetine, placebo
- Keywords
- cannabis abuse, atomoxetine, ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
atomoxetine
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atomoxetine prescribed daily Receives: Drug: Atomoxetine |
| 2 | Placebo comparator | placebo controlled arm Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD response and reduction in ADHD symptoms; measured at Week 12
Measured: 12 weeks of trial or length of participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2007
- Study completionJan 2007
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frances R Levin, New York State Psychiatric Institute
- Investigators
- Frances R Levin, M.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142961
- Sponsor's protocol ID
- #4988-NIDA-19233-1
- Other IDs
- R01DA019233, DPMCDA
- Status last verified
- Apr 2019
- First submitted
- 1 Sep 2005
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marijuana-Abusing Attention Deficit Hyperactivity Disorder (ADHD) Teens: Atomoxetine Treatment
- ClinicalTrials.gov ID
- NCT00142961
- Acronym / sponsor ID
- #4988-NIDA-19233-1
- Keywords
- cannabis abuse, atomoxetine, ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 2 Sep 2005 (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.
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. The purpose of this study is to determine the use of atomoxetine in treating adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms as compared to a placebo. Finally, the study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
Detailed description
Attention Deficit Hyperactivity Disorder (ADHD) is common among adolescents seeking treatment for marijuana dependence. Therefore, it is important to develop treatments targeting adolescents diagnosed with both ADHD and marijuana dependence. Atomoxetine is currently used to treat individuals diagnosed with ADHD. The purpose of this study is to determine the feasibility of administering atomoxetine in a therapeutic setting to adolescents who abuse marijuana and have ADHD. In addition, this study will assess whether atomoxetine reduces ADHD symptoms. Finally, this study will determine whether atomoxetine improves treatment retention and progress in adolescents with ADHD and marijuana dependence.
Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo. Study visits will occur 2 times each week for the duration of the 12-week trial. At each study visit, vital signs and medication side effects will be assessed. In addition, psychiatric ratings measurements will be evaluated. Participants will also complete self reports in order to track ADHD-related symptoms. Starting at the Week 2 study visit, all participants will receive psychotherapy sessions. This will involve cognitive-behavioral therapy/relapse prevention treatment that has been designed specifically for ADHD adolescents. The aim of the cognitive skills training will be to assist the participants in developing the skills necessary to manage their drug use as well as the symptoms they experience related to ADHD. At Month 6, a follow-up visit will occur, at which time participants urine toxicology tests will be completed to determine if participants have been using marijuana or any other substances of abuse. In addition, at the Month 6 follow-up visit, participants will complete psychiatric ratings, self reports, and will meet with a physician to assess ADHD-related symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AtomoxetineAtomoxetine prescribed daily |
| 2 | Placebo comparator | Other: placeboplacebo controlled arm |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for marijuana dependence and reports that marijuana is their primary drug of abuse
- Meets DSM-IV criteria for ADHD, as determined by the CAADID
- Females will be included if not pregnant or breastfeeding, and agree to use an adequate method of contraception for the duration of the study
Key exclusion criteria (16 listed)
- Meets DSM-IV criteria for schizophrenia, schizoaffective illness, psychotic disorder other than transient psychosis due to drug abuse, current major depression, bipolar illness, or psychiatric disorders (individuals with substance-induced mood disorder with depressive features as well as substance induced anxiety disorder will not be excluded from the study)
- Medically unstable (based on laboratory tests, an electrocardiogram, medical history, and physical examination) such that study participation would be hazardous; examples include uncontrolled high blood pressure and faster than normal heart rate (systolic blood pressure greater than 130, diastolic blood pressure greater than 80, or a resting heart rate greater than 90) or diabetes
- History of seizures
- Current suicidal risk
- Pregnant or breastfeeding
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 |
|---|---|---|
| Atomoxetineatomoxetine | Drug | 1 |
| placebo | Other | 2 |
Primary outcome
ADHD response and reduction in ADHD symptoms; measured at Week 12
Time frame: 12 weeks of trial or length of participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Substance Treatment and Research ServiceLink provided by the sponsor.
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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.
Frances R Levin, M.D. principal investigator
New York State Psychiatric Institute
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 Atomoxetine in people with Attention Deficit Disorder With Hyperactivity and Marijuana Abuse, run by New York State Psychiatric Institute 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 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 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADHD response and reduction in ADHD symptoms; measured at Week 12 (time frame: 12 weeks of trial or length of participation). 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 23 Apr 2019.