Cocaine Abuse and DependencePhase 2NCT00467389
Use of Donepezil for Treatment of Cocaine Dependence
A Phase 2 study testing Donepezil, 5 mg daily in people with Cocaine Abuse and Dependence, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine Abuse and Dependence
- What is being tested?
- Donepezil, 5 mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Sep 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or intravenous injection within the four weeks prior to screening, and must supply a cocaine-positive urine obtained within four weeks of entry into the study.
Who cannot join
- Shows signs of psychostimulant toxicity, or has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
- Has a current psychiatric disorder other than drug abuse or dependence or dementia.
- Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
- Has received opiate-substitution therapy (methadone or buprenorphine) within two months prior to enrollment.
- Has current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, or family history of seizure disorder.
- Has a diagnosis of adult asthma, or chronic obstructive pulmonary disease, including a history of acute asthma within the past two years, and those with current or recent (with the past two years) treatment with an inhaled or oral beta-adrenergic agonist.
- Has had head trauma that resulted in neurological sequelae.
- Has an unstable medical condition, which, in the judgement of investigators, would make participation hazardous.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Donepezil Effects on Cocaine Craving and Pharmacokinetics
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
Read the detailed description
This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.
- Conditions
- Cocaine Abuse and Dependence
- Being tested
- Donepezil, 5 mg daily, Oral Placebo
- Keywords
- Acetylcholine, Acetylcholinesterase, Butyrylcholinesterase, Cholinesterase Inhibitor
- Medical subject headings
- Cocaine-Related Disorders, Pain, Butyrylcholinesterase deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil, 5 mg dailyDrug
Also called Aricept
This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease.
Oral PlaceboOther
Also called Inactive Comparator
Inactive Comparator with Similar Appearance to Active Medication
| Study group | Role | What they receive |
|---|---|---|
| Oral Placebo First | Experimental | Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil Receives: Drug: Donepezil, 5 mg daily; Other: Oral Placebo |
| Donepezil First | Experimental | Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo. Receives: Drug: Donepezil, 5 mg daily; Other: Oral Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine Safety in Subjects Receiving Donepezil
Patients evaluated for clinical and laboratory adverse events
Measured: Two weeks
Secondary outcomes (2)
Cocaine Subjective Effects
Cocaine Induced 'High' by VAS (visual analogue scale, between 3 and 30 minutes after intravenous dosing, in mm). VAS results ranged from 0 (minimum effect) to 100 (maximum effect).
Measured: 3 to 30 minutes
Cocaine Pharmacokinetics
Area-Under-the-Curve for Plasma Concentration
Measured: 0 to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionSep 2008
- Study completionSep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Abuse and DependenceStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kenneth Grasing, MD, Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467389
- Sponsor's protocol ID
- NEUA-014-05S
- Status last verified
- May 2014
- First submitted
- 27 Apr 2007
- Last updated
- 9 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Grasing K, Mathur D, Newton TF, DeSouza C. Donepezil treatment and the subjective effects of intravenous cocaine in dependent individuals. Drug Alcohol Depend. 2010 Feb 1;107(1):69-75. doi: 10.1016/j.drugalcdep.2009.09.010.
PubMed 19836169
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil Effects on Cocaine Craving and Pharmacokinetics
- ClinicalTrials.gov ID
- NCT00467389
- Acronym / sponsor ID
- NEUA-014-05S
- Conditions
- Cocaine Abuse and Dependence
- Keywords
- Acetylcholine, Acetylcholinesterase, Butyrylcholinesterase, Cholinesterase Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Posted 9 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.
Detailed description
This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Placebo First | Experimental | Drug: Donepezil, 5 mg daily, Other: Oral PlaceboThree days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil |
| Donepezil First | Experimental | Drug: Donepezil, 5 mg daily, Other: Oral PlaceboThree days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-treatment seeking, experienced cocaine users, who have used cocaine by smoking or intravenous injection within the four weeks prior to screening, and must supply a cocaine-positive urine obtained within four weeks of entry into the study.
Key exclusion criteria (8 listed)
- Shows signs of psychostimulant toxicity, or has a history of a medical adverse reaction to cocaine or other psychostimulants, including loss of consciousness, chest pain, cardiac ischemia, or seizure.
- Has a current psychiatric disorder other than drug abuse or dependence or dementia.
- Meets the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for dependence to opiates, benzodiazepines, alcohol, or other sedative-hypnotics.
- Has received opiate-substitution therapy (methadone or buprenorphine) within two months prior to enrollment.
- Has current or past history of seizure disorder, including alcohol- or psychostimulant- related seizures, or family history of seizure disorder.
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 |
|---|---|---|
| Donepezil, 5 mg dailyAlso: AriceptThis is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease. | Drug | Donepezil First, Oral Placebo First |
| Oral PlaceboAlso: Inactive ComparatorInactive Comparator with Similar Appearance to Active Medication | Other | Donepezil First, Oral Placebo First |
Primary outcome
Cocaine Safety in Subjects Receiving Donepezil
Time frame: Two weeks
Patients evaluated for clinical and laboratory adverse events
2 secondary outcomes
Cocaine Subjective Effects
Time frame: 3 to 30 minutes
Cocaine Pharmacokinetics
Time frame: 0 to 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19836169Grasing K, Mathur D, Newton TF, DeSouza C. Donepezil treatment and the subjective effects of intravenous cocaine in dependent individuals. Drug Alcohol Depend. 2010 Feb 1;107(1):69-75. doi: 10.1016/j.drugalcdep.2009.09.010.
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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.
Kenneth Grasing, MD principal investigator
VA Medical Center
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 Donepezil, 5 mg daily in people with Cocaine Abuse and Dependence, run by US Department of Veterans Affairs 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 1 inclusion and 8 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 9 Jun 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. 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 Jun 2014). 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?
Cocaine Safety in Subjects Receiving Donepezil (time frame: Two weeks). 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 NCT00467389, 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 9 Jun 2014.