| ID | Type | Description | Link |
|---|---|---|---|
| R21DA018221 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The aim of the study is to determine if atomoxetine treatment combined with motivational enhancement therapy is effective in reducing marijuana use in adult individuals with attention-deficit hyperactivity disorder and marijuana dependence.
The purpose of this study is to determine whether the medication atomoxetine, or Strattera, plus 3 sessions of counseling can help people to reduce the symptoms of ADHD and to help cut back on their marijuana use. Participation in the study is approximately 12 weeks of medication treatment and doctor's visits once a week. The first 2 visits consist of evaluations to determine if you qualify to participate. These visits are approximately 2-3 hours long and will include questions about your past and present substance use, psychiatric history, a routine physical exam, bloodwork, and paper and pencil questionnaires about your marijuana use. Once you are enrolled in the study, visits are typically 30 minutes long, once a week. The one-on-one counseling sessions regarding marijuana use are 1 hour long and you will have 3 sessions throughout the study. If you qualify for this study, you will receive either atomoxetine, or a placebo (sugar pill). Study participants will have a 50% chance of receiving atomoxetine. Atomoxetine is a non-stimulant, commonly used to treat ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Atomoxetine plus Motivational Enhancement Therapy |
|
| Placebo | Placebo Comparator | Placebo plus Motivational Enhancement Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | 25 to 100 mg daily |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Estimated Week 12 Self-reported Use | Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back. | One week (study week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Longitudinal Use | Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back. | 12 weeks |
| Urine Drug Screens |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aimee L McRae, PharmD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29489073 | Derived | Chauchard E, Hartwell KJ, McRae-Clark AL, Sherman BJ, Gorelick DA. Cannabis Withdrawal in Adults With Attention-Deficit/Hyperactivity Disorder. Prim Care Companion CNS Disord. 2018 Feb 22;20(1):17m02203. doi: 10.4088/PCC.17m02203. |
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Participants recruited between November 2005 and June 2008 primarily through media advertisements and fliers
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Flexible dose up to 100mg/day |
| FG001 | Placebo | Flexible dose up to 100mg/day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Flexible dose up to 100mg/day |
| BG001 | Placebo | Flexible dose up to 100mg/day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Self-reported Longitudinal Use | Participants' self-report of mean frequency of use of marijuana from baseline through week 12 visit of the study was assessed using a Time-Line Follow-Back. | Posted | Mean | Standard Deviation | Percentage of days used | 12 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atomoxetine | Flexible dose up to 100mg/day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety/depression | Psychiatric disorders | Non-systematic Assessment |
Small sample size and poor retention
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aimee McRae-Clark, Pharm.D., BCPP | Medical University of South Carolina | 843-792-5215 | mcraeal@musc.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| D062405 | Motivational Interviewing |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D037001 | Directive Counseling |
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| Motivational enhancement therapy | Procedure | Three sessions |
|
|
| Placebo | Drug | 25 to 100 mg daily |
|
|
Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.
| 12 weeks |
| Wender-Reimherr Adult Attention Deficit Disorder Scale | The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0-2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF). | Baseline and Week 12 |
| Clinical Global Impression, Improvement Scale | The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | 12 weeks |
| Adverse Event |
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| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Estimated Week 12 Self-reported Use | Participants' self-report of mean frequency of use of marijuana during week 12 of the study was assessed using a Time-Line Follow-Back. | Posted | Mean | Standard Error | Times per day | One week (study week 12) |
|
|
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| Secondary | Urine Drug Screens | Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group. | Posted | Number | Percentage of positive UDS | 12 weeks |
|
|
|
| Secondary | Wender-Reimherr Adult Attention Deficit Disorder Scale | The WRAADDS is intended to measure the severity of ADHD symptoms in adults. It measures symptoms in seven categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional over-reactivity, disorganization, and impulsivity. The scale rates individual items from 0-2 (0=not present, 1=mild, 2=clearly present), with a minimum score of 0 and maximum score of 46. Reported here is change from Baseline to Week 12 (or LOCF). | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
|
|
|
| Secondary | Clinical Global Impression, Improvement Scale | The Clinical Global Impression - Improvement scale (CGI-I) was used to assess improvement in ADHD symptoms during study participation. CGI-I is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| 0 |
| 19 |
| 19 |
| 19 |
| EG001 | Placebo | Flexible dose up to 100mg/day | 0 | 19 | 16 | 19 |
| Dizziness/lightheaded | Nervous system disorders | Non-systematic Assessment |
|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Dry mouth | General disorders | Non-systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Hot/cold flashes | General disorders | Non-systematic Assessment |
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| Increased urination | Renal and urinary disorders | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | Non-systematic Assessment |
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| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Sexual dysfunction | Reproductive system and breast disorders | Non-systematic Assessment |
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| Sinus/allergies/flu-like symptoms | General disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment |
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| D065886 | Neurodevelopmental Disorders |
| D003376 |
| Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002241 | Carbohydrates |