Attention Deficit Hyperactivity DisorderPhase 4NCT00936299

Bupropion for ADHD in Adolescents With Substance Use Disorder

A Phase 4 study testing Bupropion in people with Attention Deficit Hyperactivity Disorder and Nicotine Dependence, run by University of Colorado, Denver 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

Who is it for?: Ages 13 to 19 years
Conditions the study is for: Attention Deficit Hyperactivity Disorder, Nicotine Dependence, Cannabis Use Disorder
What is being tested?: Bupropion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 105 participants
Where: 1 siteUnited States
Study dates: Jan 2009to May 2013
Phase: Phase 4
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 13 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Between the ages of 13 and 19, with a parent or legal guardian available to complete parental assessments for minors;
Meet DSM-IV diagnostic criteria for ADHD on the K-SADS-PL;
Schedule for Affective Disorders and Schizophrenia score ≥ 22 on the DSM-IV ADHD symptom checklist;
Meet DSM-IV criteria for nicotine dependence (and/or cut off score of >3 on modified Fagerstrom);
Meet DSM-IV criteria for cannabis abuse or dependence on the Kiddie-Sads-Present and Lifetime (K-SADS-PL);
Have used marijuana at least 5 of the past 30 days;

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Have used nicotine at least 15 days out of the past 30 days;
Be medically healthy;
If female, subjects must use an effective birth control method if sexually active.

Who cannot join

Current or past psychosis;
Bipolar I or II disorder;
A first-degree relative with bipolar I disorder;
A lifetime history of seizure disorder;
Any other chronic or serious medical illnesses;
A lifetime history of eating disorder;

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Current pregnancy;
Previous clinically significant adverse reaction to bupropion;
The need to take other psychotropic medications at the time of study entry. Patients may have had previous psychotherapy or pharmacotherapy for ADHD or other co-morbidity but cannot have been on psychotropic medication for at least one month prior to study entry;
Active participation in substance abuse treatment or mental health treatment (including outpatient, day-treatment, residential, or inpatient) within 28 days prior to signing consent;
Non-English speaking (due to the difficulty in translating the additional materials given to the subjects);
Cognitively impaired or of low intelligence;
Breastfeeding;
Current use of other psychotropic medications including nicotine replacement therapy;
Current opiate dependence.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Denver, Adolescent Clinical Research
Denver, Colorado, 80210

Other trials in United States

About this study

Attention deficit hyperactivity disorder (ADHD) is one of the most common co-occurring psychiatric disorders (30-50%) in adolescents with substance use disorders (SUD). Yet, little is known about the safety and efficacy of medications for ADHD in adolescents with SUD, since such youths have been excluded from most medication trials. Clinicians are therefore understandably reluctant to treat ADHD in substance abusing adolescents, often first referring such youths to substance treatment. Untreated ADHD is associated with poorer substance treatment outcomes. We address this research gap by proposing a randomized controlled trial of bupropion vs placebo in 130 adolescents (13-19 years) with Diagnostic and Statistical Manual (DSM IV) ADHD, nicotine dependence and cannabis use disorder (not excluding other SUD). Participants in both bupropion and placebo treatment groups will receive weekly individual manualized-standardized cognitive behavioral therapy (CBT) targeting SUD (at no cost to them) throughout the 16 weeks of the medication trial. Bupropion also is effective in treating nicotine dependence in adults; the majority of adolescents with marijuana and other drug abuse also smoke tobacco. More recent research in adults indicates that bupropion may reduce craving and use of other substances of abuse (e.g. methamphetamine, cocaine). It's possible impact on cannabis use disorder (the addiction for which most teens are referred to treatment) has not yet been evaluated. However since all drugs of abuse have a final common pathway leading to addiction via action in the so called brain reward system (ventral tegmental area (VTA), accumbens) -an important secondary aim is to evaluate bupropion's potential impact on craving and use of marijuana (MJ) in addition to its known similar action on nicotine.

Read the detailed description

Research has shown that bupropion is a safe and effective treatment for both ADHD and nicotine dependence in individuals without SUD, and newer research provides empirical support for its unique pharmacotherapeutic properties and potential for treating other addictive disorders (e.g., methamphetamine dependence, pathological gambling). No controlled studies have yet evaluated bupropion's safety and efficacy for ADHD and SUD (including nicotine and cannabis) in adolescents. The lack of research on the safety and efficacy of medications in adolescents with SUD and psychiatric comorbidities contributes to a serious lack of integrated treatment for commonly co-occurring mental health and substance problems in community-based adolescent drug treatment programs. This then contributes to poorer treatment outcomes and prognosis for the large number of comorbid youths with substance abuse and mental health problems that significantly impact public health. The specific aims of the proposed study will address this research gap by conducting a 16-week randomized controlled trial of bupropion vs. placebo to evaluate the safety and efficacy of this low abuse potential medication on ADHD, nicotine dependence, and cannabis use disorders (not excluding other SUD) in 130 adolescents (13-19) receiving concurrent outpatient substance treatment (CBT). The study design and analytic approach will enable assessment of the complex inter-relationship between change in ADHD, depression/dysphoria (and other psychiatric symptoms) and change in nicotine, cannabis and other substance use within and between treatment groups. Thus, the study addresses important research gaps in at least two priority areas of the National Institute on Drug Abuse/ National Institutes of Health(NIDA/NIH) research agenda: 1) research on effective treatments for adolescents with addiction and psychiatric comorbidity, and 2) medications development research for nicotine and cannabis use disorders in adolescents.

Conditions: Attention Deficit Hyperactivity Disorder, Nicotine Dependence, Cannabis Use Disorder
Being tested: Bupropion, Placebo
Keywords: Adolescents, Substance Use Disorder, Attention Deficit Hyperactivity Disorder, Cognitive Behavioral Therapy
Medical subject headings: Attention Deficit Disorder with Hyperactivity, Tobacco Use Disorder, Substance-Related Disorders

What participants receive

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

BupropionDrug
Bupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy
PlaceboOther
Also called Sugar Pill

Study groups in NCT00936299
Study group	Role	What they receive
Bupropion + cognitive behavioral therapy	Active comparator	Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT. Receives: Drug: Bupropion
Placebo + cognitive behavioral therapy	Placebo comparator	Adolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT. Receives: Other: Placebo

What is being measured

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

Change in ADHD Rating Scale (ADHD-RS) Total Score
DSM-IV ADHD Rating Scale (ADHD-RS) Total Score (clinician administered/adolescent informant). Total scale range 0-54, higher is greater severity.
Measured: Baseline, 16 Weeks
Change in Number of Days of Cigarette Smoking in Past 28 Days
The number of days of cigarette smoking in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cigarette smoking at baseline was compared to mean number of days of past 28-day cigarette smoking at end of 16-week trial.
Measured: Baseline, 16 Weeks

Secondary outcomes (1)

Change in Number of Days of Cannabis Use in Past 28 Days
The number of days of cannabis use in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cannabis use at baseline was compared to mean number of days of past 28-day cannabis use at end of 16-week trial.
Measured: Baseline, 16 Weeks

Timeline

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

Jan 2009May 2013

First posted10 Jul 2009 (estimated)
Study startJan 2009
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00936299
Sponsor's protocol ID: 08-0178
Other IDs: R01DA022284
Status last verified: Dec 2019
First submitted: 8 Jul 2009
Last updated: 23 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bupropion for ADHD in Adolescents With Substance Use Disorder
ClinicalTrials.gov ID: NCT00936299
Acronym / sponsor ID: 08-0178
Conditions: Attention Deficit Hyperactivity Disorder, Nicotine Dependence, Cannabis Use Disorder
Keywords: Adolescents, Substance Use Disorder, Attention Deficit Hyperactivity Disorder, Cognitive Behavioral Therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 105 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jan 2009
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 10 Jul 2009 (estimated)
Results: Posted 3 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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
Bupropion + cognitive behavioral therapy	Active comparator	Drug: BupropionAdolescents with ADHD, nicotine dependence, and cannabis use disorders receive bupropion + CBT.
Placebo + cognitive behavioral therapy	Placebo comparator	Other: PlaceboAdolescents with ADHD, nicotine dependence, and cannabis use disorders receive placebo + CBT.

Who may qualify

Ages: 13 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Between the ages of 13 and 19, with a parent or legal guardian available to complete parental assessments for minors;
Meet DSM-IV diagnostic criteria for ADHD on the K-SADS-PL;
Schedule for Affective Disorders and Schizophrenia score ≥ 22 on the DSM-IV ADHD symptom checklist;
Meet DSM-IV criteria for nicotine dependence (and/or cut off score of >3 on modified Fagerstrom);
Meet DSM-IV criteria for cannabis abuse or dependence on the Kiddie-Sads-Present and Lifetime (K-SADS-PL);

Key exclusion criteria (15 listed)

Current or past psychosis;
Bipolar I or II disorder;
A first-degree relative with bipolar I disorder;
A lifetime history of seizure disorder;
Any other chronic or serious medical illnesses;

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
BupropionBupropion (target dose 300 mg/day) + cognitive behavioral therapy; matched placebo + cognitive behavioral therapy	Drug	Bupropion + cognitive behavioral therapy
PlaceboAlso: Sugar Pill	Other	Placebo + cognitive behavioral therapy

Primary outcome

Change in ADHD Rating Scale (ADHD-RS) Total Score
Time frame: Baseline, 16 Weeks
DSM-IV ADHD Rating Scale (ADHD-RS) Total Score (clinician administered/adolescent informant). Total scale range 0-54, higher is greater severity.
Change in Number of Days of Cigarette Smoking in Past 28 Days
Time frame: Baseline, 16 Weeks
The number of days of cigarette smoking in the past 28 days was ascertained based on adolescent self-report using calendar-based timeline follow back procedures. Mean number of days of past 28-day cigarette smoking at baseline was compared to mean number of days of past 28-day cigarette smoking at end of 16-week trial.

1 secondary outcome

Change in Number of Days of Cannabis Use in Past 28 Days
Time frame: Baseline, 16 Weeks

Results and safety

Results posted to the registry on 3 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupropion + Cognitive Behavioral Therapy	53	40
Placebo + Cognitive Behavioral Therapy	52	40

Primary outcome: Change in ADHD Rating Scale (ADHD-RS) Total Score

Time frame: Baseline, 16 Weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Bupropion + Cognitive Behavioral Therapy n = 53	Placebo + Cognitive Behavioral Therapy n = 52
Value	-14.2 (-17.1 to -11.4)	-13.8 (-16.6 to -11.1)

Primary outcome: Change in Number of Days of Cigarette Smoking in Past 28 Days

Time frame: Baseline, 16 Weeks. Mean (95% Confidence Interval). Unit: days of use

Measure	Bupropion + Cognitive Behavioral Therapy n = 53	Placebo + Cognitive Behavioral Therapy n = 52
Value	-4.1 (-6.7 to -1.5)	-2.7 (-5.3 to -0.1)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bupropion + Cognitive Behavioral Therapy	2 of 53 (3.8%)	45 of 53 (84.9%)	Not reported
Placebo + Cognitive Behavioral Therapy	2 of 52 (3.8%)	45 of 52 (86.5%)	Not reported

Limitations and caveats (from the sponsor): Actual study enrollment N=105 was less than targeted enrollment N=130. Thus, negative results should be interpreted with caution because the study was likely underpowered.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Attention Deficit Hyperactivity Disorder

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Not yet recruitingPhase 2
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RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
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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.

Paula D Riggs, M.D. principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupropion in people with Attention Deficit Hyperactivity Disorder and Nicotine Dependence, run by University of Colorado, Denver 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 9 inclusion and 15 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 Dec 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 3 Dec 2019). 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?

Change in ADHD Rating Scale (ADHD-RS) Total Score (time frame: Baseline, 16 Weeks). 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?

On the ClinicalTrials.gov record for NCT00936299.

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 Dec 2019.