Effectiveness of Atomoxetine in Treating Marijuana Dependent Individuals Diagnosed With Attention Deficit Hyperactivity Disorder - 1

It is estimated that between 1% and 6% of the general adult population exhibit symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Adult ADHD is often associated with substance abuse, specifically marijuana. The purpose of this study is to evaluate the safety and effectiveness of atomoxetine in treating adults dually diagnosed with ADHD and marijuana dependence.

Condition	Intervention	Phase
Atention Deficit Disorder With Hyperactivity Marijuana Abuse	Drug: Atomoxetine	Phase II

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcomes: Self-reports of substance abuse; measured at Week 12
Secondary Outcomes: ADHD symptoms; measured at Week 12; Substance use; measured at Week 12
Expected Total Enrollment:  70

Marijuana is one of the most commonly used drugs by adults with ADHD. Currently, there is no consensus on the medication of choice for treating ADHD in adults. There is even less information on the appropriate pharmacotherapy for adults dually diagnosed with ADHD and a substance use disorder (SUD) such as marijuana dependence. Although stimulant medications (e.g., methylphenidate, pemoline, d-amphetamine) have been used to treat ADHD in children, they are avoided in the adult substance-abusing population due to their abuse potential. Atomoxetine is a non-stimulant drug that has recently been approved for the treatment of ADHD. Due to its non-abusive properties, atomoxetine holds potential as a treatment choice. The purpose of this study is to evaluate the safety and effectiveness of atomoxetine in treating adults dually diagnosed with ADHD and marijuana dependence.

Participants in this 12-week, double-blind study will be randomly assigned to receive either atomoxetine or placebo. Those receiving atomoxetine will follow a flexible dosage regimen of up to 100 mg of atomoxetine per day. All participants will receive three sessions of motivational enhancement therapy. Study visits will include self-reports of marijuana use, interviews, ADHD ratings, and urine tests for marijuana.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Meets DSM-IV criteria for marijuana dependence
• Meets DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD), as determined by a clinical interview and confirmed by a semi-structured interview with the Conners' Adult ADHD Diagnostic Interview for DSM-IV
• Scores greater than 12 on the Wender-Reimherr Adult Attention Deficit Disorder Scale
• ADHD symptoms that can be confirmed by another individual (significant other, friend, parent, or sibling)
• Lives within a 60-mile radius of Charleston, SC

Exclusion Criteria:

• Meets DSM-IV criteria for dependence on a substance other than marijuana, nicotine, or caffeine
• Meets DSM-IV criteria for a lifetime history of schizophrenia, other non-affective psychotic disorder, or bipolar disorder
• Meets DSM-IV criteria for current major depressive disorder or eating disorder
• Significant suicidal risk
• Significant cognitive impairment, as determined by a score of less than 26 on the Mini-Mental Status Exam
• Currently taking stimulants, benzodiazepines, antidepressant or antipsychotic medications
• Currently receiving psychotherapy focused on reducing marijuana use or ADHD symptoms
• Pregnant or breastfeeding
• Unwilling to use an adequate method of contraception for the duration of the study
• Without stable housing
• Major medical illnesses (e.g., HIV, kidney failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
• High blood pressure, defined as a blood pressure greater than 140/90, measured on 3 or more occasions
• Evidence of liver insufficiency
• Urinary hesitancy
• Individuals who, in the opinion of the study investigator, would not be able to comply with study procedures, such as individuals unable to be reliably present for intake appointments
• Currently being treated with medication for ADHD

Please refer to this study by ClinicalTrials.gov identifier  NCT00227851

Stacey Simpson, M.A.      (843)792-4815    simpsost@musc.edu

South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting

Study chairs or principal investigators

Aimee Mcrae, Pharm.D.,  Principal Investigator,  Medical University of South Carolina   

Study ID Numbers:  NIDA-18221-1; R21-18221-1; DPMC
Last Updated:  November 21, 2005
Record first received:  September 27, 2005
ClinicalTrials.gov Identifier:  NCT00227851
Health Authority: United States: Federal Government

 

 

Attention Deficit Disorder with Hyperactivity (National Library of Medicine)

Attention-Deficit/Hyperactivity Disorder - Symptoms of ADHD  (National Center on Birth Defects and Developmental Disabilities)

ADHD  (Nemours Foundation)

What Is Hyperactivity?  (Nemours Foundation)

ADHD Medications  (Nemours Foundation)

ADHD – References  (Centers for Disease Control and Prevention)

ADHD Medicines  (Nemours Foundation)

ADHD and Risk of Injuries  (National Center on Birth Defects and Developmental Disabilities)

ClinicalTrials.gov: Attention Deficit Disorder with Hyperactivity  (National Institutes of Health)

Peer Relationships and ADHD  (National Center on Birth Defects and Developmental Disabilities)

Attention-Deficit/Hyperactivity Disorder  (Mayo Foundation for Medical Education and Research)

ADHD -- Establishing a Treatment Plan  (American Academy of Pediatrics)

ADHD: Not Just for Kids Anymore  (Food and Drug Administration)

ADHD -- Common Behaviors and Symptoms  (American Academy of Pediatrics)

Attention Deficit Hyperactivity Disorder  (National Institute of Mental Health)

Attention Deficit-Hyperactivity Disorder  (National Institute of Neurological Disorders and Stroke)

ADHD -- Evaluating the Treatment Plan  (American Academy of Pediatrics)

ADHD and Teens  (American Academy of Pediatrics)

ADHD: Does My Child Have It?  (American Academy of Family Physicians)

Hispanic-American Youths Less Likely to Receive ADHD Diagnosis  (Nemours Foundation)

ADHD -- Unproven Treatments  (American Academy of Pediatrics)

Many Children with ADHD Fail to Get Adequate Follow-Up Visits  (Nemours Foundation)

Helping Children and Youth with Attention-Deficit/Hyperactivity Disorder: Systems of Care  (Center for Mental Health Services)

ADHD Medicines  (American Academy of Family Physicians)

Children of Moms Who Smoked during Pregnancy More Likely to Have ADHD  (Nemours Foundation)

ADHD -- Making the Diagnosis  (American Academy of Pediatrics)

Marijuana

Marijuana (National Library of Medicine)

ClinicalTrials.gov: Marijuana Abuse  (National Institutes of Health)

What You Need to Know about Drugs: Marijuana  (Nemours Foundation)

Street Terms: Drugs and the Drug Trade: Marijuana  (Office of National Drug Control Policy)

Marijuana  (Office of National Drug Control Policy)

Marijuana  (Office of National Drug Control Policy)

Daily Marijuana Users  (Substance Abuse and Mental Health Services Administration)

Marijuana  (National Institute on Drug Abuse)

Marijuana's Adverse Effects  (American Academy of Family Physicians)

Teens and the Risk of Marijuana Use  (Nemours Foundation)

Marijuana: Facts for Teens  (National Institute on Drug Abuse)

Marijuana Abuse  (National Institute on Drug Abuse)

Marijuana: Facts Parents Need to Know  (National Institute on Drug Abuse)

Tips for Teens: The Truth about Marijuana  (National Clearinghouse for Alcohol and Drug Information)

Adult Marijuana Admissions by Race and Ethnicity: 2000  (Substance Abuse and Mental Health Services Administration)

Marijuana as Medicine? Pros and Cons  (Mayo Foundation for Medical Education and Research)

Twin Study Links Marijuana Abuse, Suicide, and Depression  (National Institute on Drug Abuse)

Trends in Marijuana Treatment Admissions, by State: 1992-2002  (Substance Abuse and Mental Health Services Administration)

Marijuana Quest  (National Institute on Drug Abuse)

Age at First Use of Marijuana and Past Year Serious Mental Illness  (Substance Abuse and Mental Health Services Administration)

Driving toward Disaster? Steer Your Teen Away from Marijuana  (Substance Abuse and Mental Health Services Administration)