Cocaine DependencePhase 2NCT00322309
Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
A Phase 2 study testing Mirtazapine in people with Cocaine Dependence and Depression, run by Boston University at 1 site in United States.
Trial summary
This research study is being done to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Dependence, Depression
- What is being tested?
- Mirtazapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Feb 2010
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnostic Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of cocaine dependence.
- HAM-D score of 12 or above and history of autonomous depression, defined as meeting DSM-IV criteria for major depression or dysthymic disorder during any lifetime period of abstinence of 30 days or longer.
- At least one urine toxicology positive for cocaine benzoylecgonine (BE) over the consecutive two-week baseline screening period during which 6 urine samples have been obtained
- Males and non-pregnant, non-nursing females, 18-64 years of age (inclusive).
- Individuals able to give written informed consent and willing to comply with all study procedures.
Who cannot join
- Any Axis I diagnosis that, in the opinion of the Principal Investigator, may interfere with the course of the trial.
- Physiological dependence on alcohol or opiates requiring medical detoxification.
- A medical or neurological illness that in the clinical judgment of the investigator would make study compliance difficult or contraindicate the use of mirtazapine.
- Any clinically significant abnormal lab values or liver function tests (LFTs) which are greater than 3 times the normal limit.
- The need or intention to use concurrently with or within four weeks prior to study drug administration, any of the following medications: monoamine oxidase inhibitors and/or sibutramine. In addition, other medications such as alpha2-agonists and medications which affect the enzymes Cytochrome P450 1A2 (CYP1A2), Cytochrome P450 2D6 (CYP2D6), Cytochrome P450 3A4 (CYP3A4) (as inhibitors, substrates, or inducers), and serotonin modulators should be used with caution. The research physician will decide on this issue. A listing of these substances may be found in Appendix I.
- Females of childbearing potential who do NOT agree to use a medically acceptable method of birth control (barrier, intrauterine device (IUD), oral or depot contraceptive medication, or complete abstinence).
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- Positive pregnancy test.
- Breastfeeding
- Known drug allergy or sensitivity to mirtazapine.
- Participation in an investigational drug or device study within 1 month of enrollment in the present study.
- Enrollment in an opiate-substitution (i.e., methadone, levo acetyl methadol (LAAM)) treatment program within 45 days of enrolling in the present study.
- Individuals having taken LAAM, methadone or naltrexone within 14 days of enrollment in the present study.
- Individuals who, in the clinical judgment of the Investigator, are actively and acutely suicidal.
- Subjects, who in the opinion of the investigator, have a medical condition that may interfere with study assessments and/or put them at undue risk.
- Subjects, who in the opinion of the investigator, will have difficulty complying with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
This research study is being done to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A greater increase in Clinician Global Impression (CGI) score will be observed in the MG than in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions that necessitate termination from the study by one of the study clinicians will not differ between the MG and CG. V. Retention will be greater in MG than in CG.
Read the detailed description
Cocaine dependence is a significant public health problem associated with serious medical, psychiatric, social and economic consequences. It is generally accepted that the euphoria associated with cocaine use is a result of its action on reward pathways via antagonist properties at the dopamine transporter site; cocaine also inhibits reuptake of serotonin and norepinephrine. These actions are thought to underlie cocaine's potent reinforcing properties. With prolonged use, cocaine may deplete these neurotransmitters, affect postsynaptic receptor density, and elicit an overall dysregulation of these neurotransmitter systems. These longer term consequences may account for the post-cocaine depressive symptoms often claimed by cocaine users to contribute to relapse. Treatment for cocaine dependence at the present is primarily psychosocial/behavioral. Currently there is no pharmacological agent approved for treatment of cocaine dependence in conjunction with psychosocial interventions. Several drugs currently approved for other indications are presently under consideration for treatment of cocaine dependence based on their known mechanisms and sites of action. Current approaches include strategies to (1) block the effects of cocaine, (2) substitutes for cocaine, (3) reduce craving or enhance the addict's ability to manage his/her response to craving, and (4) treat underlying conditions (or consequences of cocaine use) that may predispose toward dependence.
- Conditions
- Cocaine Dependence, Depression
- Being tested
- Placebo, Mirtazapine
- Keywords
- Cocaine, Substance Abuse
- Medical subject headings
- Cocaine-Related Disorders, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84
MirtazapineDrug
Also called Remeron
Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Experimental | Mirtazapine administration as follows:
Days 1-4 15mg of mirtazapine daily Days 5-9 30mg of mirtazapine daily Days 10-78 45mg of mirtazapine daily Days 79-81 30mg of mirtazapine daily Days 82-84 15mg of mirtazapine daily Receives: Drug: Mirtazapine |
| Placebo- Sugar pill | Placebo comparator | Matched Placebo given daily days 1-84 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ln Benzoylecgonine Concentration
Measured: Week 11
Secondary outcomes (4)
The Clinical Global Impression Observer (CGI-O)Comparison for Week 11
Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.
Measured: Week 11
Hamilton Depression Rating Scale
Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.
Measured: Week 11
Pill Count
Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.
Measured: Weeks 1 to 11
Percent Urines Positive for Riboflavin
This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.
Measured: Weeks 1-11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2006 (estimated)
- Study startSep 2005
- Primary completionJul 2009
- Study completionFeb 2010
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 Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Afshar, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322309
- Sponsor's protocol ID
- H-22530
- Status last verified
- Apr 2017
- First submitted
- 3 May 2006
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
- ClinicalTrials.gov ID
- NCT00322309
- Acronym / sponsor ID
- H-22530
- Conditions
- Cocaine Dependence, Depression
- Keywords
- Cocaine, Substance Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 May 2006 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A greater increase in Clinician Global Impression (CGI) score will be observed in the MG than in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions that necessitate termination from the study by one of the study clinicians will not differ between the MG and CG. V. Retention will be greater in MG than in CG.
Detailed description
Cocaine dependence is a significant public health problem associated with serious medical, psychiatric, social and economic consequences. It is generally accepted that the euphoria associated with cocaine use is a result of its action on reward pathways via antagonist properties at the dopamine transporter site; cocaine also inhibits reuptake of serotonin and norepinephrine. These actions are thought to underlie cocaine's potent reinforcing properties. With prolonged use, cocaine may deplete these neurotransmitters, affect postsynaptic receptor density, and elicit an overall dysregulation of these neurotransmitter systems. These longer term consequences may account for the post-cocaine depressive symptoms often claimed by cocaine users to contribute to relapse. Treatment for cocaine dependence at the present is primarily psychosocial/behavioral. Currently there is no pharmacological agent approved for treatment of cocaine dependence in conjunction with psychosocial interventions. Several drugs currently approved for other indications are presently under consideration for treatment of cocaine dependence based on their known mechanisms and sites of action. Current approaches include strategies to (1) block the effects of cocaine, (2) substitutes for cocaine, (3) reduce craving or enhance the addict's ability to manage his/her response to craving, and (4) treat underlying conditions (or consequences of cocaine use) that may predispose toward dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Experimental | Drug: MirtazapineMirtazapine administration as follows: Days 1-4 15mg of mirtazapine daily Days 5-9 30mg of mirtazapine daily Days 10-78 45mg of mirtazapine daily Days 79-81 30mg of mirtazapine daily Days 82-84 15mg of mirtazapine daily |
| Placebo- Sugar pill | Placebo comparator | Other: PlaceboMatched Placebo given daily days 1-84 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnostic Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of cocaine dependence.
- HAM-D score of 12 or above and history of autonomous depression, defined as meeting DSM-IV criteria for major depression or dysthymic disorder during any lifetime period of abstinence of 30 days or longer.
- At least one urine toxicology positive for cocaine benzoylecgonine (BE) over the consecutive two-week baseline screening period during which 6 urine samples have been obtained
- Males and non-pregnant, non-nursing females, 18-64 years of age (inclusive).
- Individuals able to give written informed consent and willing to comply with all study procedures.
Key exclusion criteria (15 listed)
- Any Axis I diagnosis that, in the opinion of the Principal Investigator, may interfere with the course of the trial.
- Physiological dependence on alcohol or opiates requiring medical detoxification.
- A medical or neurological illness that in the clinical judgment of the investigator would make study compliance difficult or contraindicate the use of mirtazapine.
- Any clinically significant abnormal lab values or liver function tests (LFTs) which are greater than 3 times the normal limit.
- The need or intention to use concurrently with or within four weeks prior to study drug administration, any of the following medications: monoamine oxidase inhibitors and/or sibutramine. In addition, other medications such as alpha2-agonists and medications which affect the enzymes Cytochrome P450 1A2 (CYP1A2), Cytochrome P450 2D6 (CYP2D6), Cytochrome P450 3A4 (CYP3A4) (as inhibitors, substrates, or inducers), and serotonin modulators should be used with caution. The research physician will decide on this issue. A listing of these substances may be found in Appendix I.
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 |
|---|---|---|
| PlaceboPlacebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84 | Other | Placebo- Sugar pill |
| MirtazapineAlso: RemeronDays 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg | Drug | Mirtazapine |
Primary outcome
Ln Benzoylecgonine Concentration
Time frame: Week 11
4 secondary outcomes
The Clinical Global Impression Observer (CGI-O)Comparison for Week 11
Time frame: Week 11
Hamilton Depression Rating Scale
Time frame: Week 11
Pill Count
Time frame: Weeks 1 to 11
Percent Urines Positive for Riboflavin
Time frame: Weeks 1-11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Maryam Afshar, MD principal investigator
Boston University
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 Mirtazapine in people with Cocaine Dependence and Depression, run by Boston University 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 5 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 20 Apr 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 20 Apr 2017). 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?
Ln Benzoylecgonine Concentration (time frame: Week 11). 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 20 Apr 2017.