Substance AbusePhase 2NCT00617201
Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
A Phase 2 study testing atomoxetine in people with Substance Abuse, run by Sharon Walsh at 1 site in United States.
Trial summary
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Seeking treatment for cocaine dependence
- Must have used cocaine in the past 30 days
Who cannot join
- Physical dependence on any drug requiring medical management
- Any major medical or psychiatric disorder that would be contraindicated for participation
- Cardiovascular disease
- Seizures or significant head injuries
- Currently taking atomoxetine
- Pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
- Conditions
- Substance Abuse
- Being tested
- atomoxetine, placebo
- Keywords
- cocaine, dependence, stimulants
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atomoxetineDrug
Also called Straterra
Once daily oral dosing
placeboDrug
Once daily oral dosing - matched placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Atomoxetine Receives: Drug: atomoxetine |
| 2 | Placebo comparator | Matched Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Urine Samples Negative for Cocaine
Total % urine samples negative for benzoylecgonine over the 12-week trial
Measured: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks
Secondary outcomes (1)
Retention
Trial retention- those who complete the 12 week dosing period
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionAug 2011
- Study completionAug 2011
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 Substance AbuseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharon Walsh
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Sharon Walsh, University of Kentucky
- Investigators
- Sharon L Walsh, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617201
- Sponsor's protocol ID
- #07-0041
- Other IDs
- R01DA022191
- Status last verified
- Aug 2017
- First submitted
- 5 Feb 2008
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atomoxetine for Cocaine Dependence: A Pilot Trial
- ClinicalTrials.gov ID
- NCT00617201
- Acronym / sponsor ID
- #07-0041
- Conditions
- Substance Abuse
- Keywords
- cocaine, dependence, stimulants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sharon WalshUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 11 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
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 |
|---|---|---|
| 1 | Experimental | Drug: atomoxetineAtomoxetine |
| 2 | Placebo comparator | Drug: placeboMatched Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Seeking treatment for cocaine dependence
- Must have used cocaine in the past 30 days
Key exclusion criteria (6 listed)
- Physical dependence on any drug requiring medical management
- Any major medical or psychiatric disorder that would be contraindicated for participation
- Cardiovascular disease
- Seizures or significant head injuries
- Currently taking atomoxetine
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 |
|---|---|---|
| atomoxetineAlso: StraterraOnce daily oral dosing | Drug | 1 |
| placeboOnce daily oral dosing - matched placebo | Drug | 2 |
Primary outcome
% Urine Samples Negative for Cocaine
Time frame: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks
Total % urine samples negative for benzoylecgonine over the 12-week trial
1 secondary outcome
Retention
Time frame: 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sharon L Walsh, Ph.D. principal investigator
University of Kentucky
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 Substance Abuse, run by Sharon Walsh 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 2 inclusion and 6 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 31 Aug 2017. 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 11 Dec 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?
% Urine Samples Negative for Cocaine (time frame: Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks). 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 31 Aug 2017.