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Marijuana AbusePhase 2NCT00360269

Atomoxetine Treatment for ADHD and Marijuana Dependence

A Phase 2 study testing Atomoxetine and Motivational enhancement therapy in people with Marijuana Abuse and Attention Deficit Disorder With Hyperactivity, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Atomoxetine and Motivational enhancement therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
Nov 2005to Jun 2008
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Healthy men and women, 18 to 65 years of age
  • Meet DSM-IV criteria for marijuana dependence
  • Meet DSM-IV criteria for current ADHD, determined by a clinical interview and confirmed by semi-structured interview with the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAAR-D; Conners et al, 1999)
  • ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr Adult Attention Deficit Disorder Scale
  • ADHD symptoms must be corroborated by a second informant on either current symptoms (by a significant other or close friend) or childhood symptoms (by a parent or older sibling)
  • All subjects will agree to and sign a written, IRB-approved informed consent
  • Subjects must live within a 60-mile radius of Charleston, SC, to facilitate study visit compliance

Who cannot join

  • Individuals meeting DSM-IV dependence for a substance other than marijuana with the exception of nicotine and caffeine. Dependence on nicotine and caffeine will be allowed since dependence on these substances commonly co-occurs with marijuana dependence and excluding these individuals would compromise study recruitment
  • Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care
  • Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications. Subjects may meet criteria for a minor mood disorder (dysthymia) and for anxiety disorders. The inclusion of subjects with these disorders will be allowed as they commonly co-exist among patients with marijuana dependence (Stephens et al, 1993)
  • Individuals who present significant suicidal risk
  • Individuals with significant cognitive impairment as measured by a score of less than 26 on the Mini-Mental Status Exam, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments
  • Individuals currently receiving stimulants, benzodiazepines, antidepressant or antipsychotic medications, as these medications could confound the effects of atomoxetine treatment
Show all 14Show fewer
  • Individuals currently receiving psychotherapy focusing on reducing marijuana use or on ADHD symptoms, as this could confound the effects of atomoxetine treatment. Participation in 12-step programs will be allowed
  • Pregnant or nursing women, or women who refuse to use adequate birth control, as atomoxetine has not been approved for use in pregnancy
  • Individuals without stable housing, as contacting these individuals would be difficult
  • Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
  • Patients with hypertension (defined as having blood pressure greater than 140/90 measured on 3 or more occasions), as atomoxetine treatment can be associated with increases in blood pressure
  • Patients with evidence of hepatic insufficiency, as atomoxetine requires hepatic metabolism
  • Patients with urinary hesitancy or urinary hesitation, as atomoxetine has been associated with some urinary hesitation in clinical trials
  • Individuals who, in the investigators' opinion, would not be able to comply with study procedures, such as individuals unable to reliably present for intake appointments

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Atomoxetine, Motivational enhancement therapy, Placebo
Medical subject headings
Marijuana Abuse, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtomoxetineDrug

    Also called Strattera

    25 to 100 mg daily

  • Motivational enhancement therapyProcedure or surgery

    Also called MET

    Three sessions

  • PlaceboDrug

    Also called Sugar pill

    25 to 100 mg daily

Study groups in NCT00360269
Study groupRoleWhat they receive
ActiveExperimentalAtomoxetine plus Motivational Enhancement Therapy
Receives: Drug: Atomoxetine; Procedure: Motivational enhancement therapy
PlaceboPlacebo comparatorPlacebo plus Motivational Enhancement Therapy
Receives: Procedure: Motivational enhancement therapy; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: One week (study week 12)

Secondary outcomes (4)

  1. 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.

    Measured: 12 weeks

  2. Urine Drug Screens

    Participants submitted a urine sample weekly. Percentage of marijuana positive urine samples were calculated per group.

    Measured: 12 weeks

  3. 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).

    Measured: Baseline and Week 12

  4. 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.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2006 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360269
Sponsor's protocol ID
R21DA018221
Other IDs
R21DA018221
Status last verified
Dec 2014
First submitted
2 Aug 2006
Last updated
30 Dec 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29489073

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atomoxetine and Motivational enhancement therapy in people with Marijuana Abuse and Attention Deficit Disorder With Hyperactivity, run by Medical University of South Carolina 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 7 inclusion and 14 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 30 Dec 2014. 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 9 Apr 2012). 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?

Estimated Week 12 Self-reported Use (time frame: One week (study week 12)). 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 NCT00360269, 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 30 Dec 2014.

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