Drug-withdrawal.Phase 2MADCNCT01949571
Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.
A Phase 2 study testing Mirtazapine (REMERON, Schering-Plough-Organon) in people with Drug-withdrawal. and Drug Abuse, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial summary
INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the high rate of relapses occurs within the first months after detoxification. In the early withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as crash, which occurs in parallel with an… Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Drug-withdrawal., Drug Abuse, Drug-induced Depressive State
- What is being tested?
- Mirtazapine (REMERON, Schering-Plough-Organon)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2007to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Who can read and write. Meet the DSM IV TR criteria for substance dependence disorder (Snuff, cocaine, ethanol and polysubstance.). That meet the ratings.
Who cannot join
- disorder subjects with a history of dependency that are not abstinent (³. 1 month). Subjects with a history of neurological diseases. Subjects with general medical illness (eg CVD, hypertension, DM). Subjects prior to the implementation of neurocognitive testing report having consumed coffee, tea, alcohol or smoked three hours conducting assessments. Subjects who take more than 3 prescription drugs. Those who report being too tired. Subjects who report not having made an effort to answer the tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Studies on Anti-addictive Therapeutic Effects of Mirtazapine in Human Subjects Addicted to Cocaine.
INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the high rate of relapses occurs within the first months after detoxification. In the early withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects of the substance, known as craving. Most of the times, these clinical symptoms act as negative reinforcement, which can be severe enough to induce a drug-relapse that greatly hampers the treatment.
TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1) To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy of reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the maintenance of abstinence in patients with cocaine dependence disorder treated with mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent on cocaine comorbid with major depressive disorder.
HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of the National Institute of Psychiatry who meet the inclusion criteria and invite them to participate voluntarily. If patients accept, send them to the principal investigator for the start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and Depression Scale Beck Scale.
Read the detailed description
Evaluation. Evaluation of cocaine craving was assessed weekly through the Cocaine Craving Questionnaire (CCQ-G) (43-46). The CCQ-G measures the desire or urge level for drug consumption throughout the 45 Likert items established in the Questionnaire. The Likert scale consisted of seven options ranging from 1 to 7. Indicating from the lowest number (1) complete disagree of questions asked/item and the highest number (7) complete agreement of questions answered/item. CCQ-G items were written in past tense, with the intention that participants could report their cocaine craving status (level) during the previous week. Main items in the CCQ-G used to assess cocaine craving defined as factors were; a). Elements that denote intense cocaine craving (factor 1); b). Items that related to the anticipation of positive results (factor 2); c). Anticipation of relief from drug-withdrawal symptoms (factor 3); and d). Items that perceived a lack of control over cocaine consumption, denoting the intention and planning for cocaine consumption (factor 4).
Each week patient were assessed about their psychopathological status through the Symptom Check List 90 (SCL-90-R) (47-50). The SCL-90 evaluate the psychological degree of "distress" shown by a subject through 90 Likert-type reagents, ranging from 0 up to 4, and grouped into nine dimensions, which include, somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.
Statistical Analysis.
Data were expressed, as mean ± SEM. To determinate the differences in score between groups over time, the data were then analyzed by a two-way repeated measures ANOVA with time (week) as the repeated measure. If there was a significant interaction between time and treatment, we then performed a Tukey's post-hoc test to detect significant differences between each one of the factors at each experimental phase. Comparisons between mean score obtained during each phase were analyzed by a two-way ANOVA (treatment x phase) followed by Tukey's test for post-hoc comparisons. The level of statistical significance was set at p < 0.05.
- Conditions
- Drug-withdrawal., Drug Abuse, Drug-induced Depressive State, AOD Craving, AODR Depressive State
- Being tested
- Mirtazapine (REMERON, Schering-Plough-Organon)
- Keywords
- Mirtazapine., Addiction., Cocaine., Cocaine-craving., Cocaine-withdrawal
- Medical subject headings
- Substance Withdrawal Syndrome, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine (REMERON, Schering-Plough-Organon)Drug
Also called MIR
During the first and second phase of the study,the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, the mirtazapine group received 15 mg of mirtazapine.
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Experimental | During the first and second phase of the study, subjects assigned to the control group received one tablet of placebo under daily basis, whereas the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, placebo group received same tablet under daily basis, whereas the mirtazapine group received 15 mg of mirtazapine. Receives: Drug: Mirtazapine (REMERON, Schering-Plough-Organon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence that Mirtazapine attenuates cocaine-craving.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJan 2007
- Primary completionJul 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug-withdrawal.Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Benito Antón Palma, Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Investigators
- Benito Antón-Palma, MD-PhD, Study director, National Institute of PsychiatryRicardo Nanni-Alvarado, Psychiatry, Principal investigator, National Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949571
- Sponsor's protocol ID
- INPRF-01-MIR
- Acronym
- MADC
- Status last verified
- Sep 2013
- First submitted
- 20 Sep 2013
- Last updated
- 24 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Afshar M, Knapp CM, Sarid-Segal O, Devine E, Colaneri LS, Tozier L, Waters ME, Putnam MA, Ciraulo DA. The efficacy of mirtazapine in the treatment of cocaine dependence with comorbid depression. Am J Drug Alcohol Abuse. 2012 Mar;38(2):181-6. doi: 10.3109/00952990.2011.644002. Epub 2012 Jan 5.
PubMed 22221171Zueco Perez PL. [Mirtazapine in the treatment of cocaine-dependence in patients with methadone]. Actas Esp Psiquiatr. 2002 Nov-Dec;30(6):337-42. Spanish.
PubMed 12487943Graves SM, Rafeyan R, Watts J, Napier TC. Mirtazapine, and mirtazapine-like compounds as possible pharmacotherapy for substance abuse disorders: evidence from the bench and the bedside. Pharmacol Ther. 2012 Dec;136(3):343-53. doi: 10.1016/j.pharmthera.2012.08.013. Epub 2012 Aug 29.
PubMed 22960395
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Studies on Anti-addictive Therapeutic Effects of Mirtazapine in Human Subjects Addicted to Cocaine.
- ClinicalTrials.gov ID
- NCT01949571
- Acronym / sponsor ID
- MADC / INPRF-01-MIR
- Conditions
- Drug-withdrawal., Drug Abuse, Drug-induced Depressive State, AOD Craving, AODR Depressive State
- Keywords
- Mirtazapine., Addiction., Cocaine., Cocaine-craving., Cocaine-withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
INTRODUCTION. One of the main problems of the treatment of cocaine-dependent patients is the high rate of relapses occurs within the first months after detoxification. In the early withdrawal phase, patients suffer severe anxious depressive symptoms, known in the argot as crash, which occurs in parallel with an appetite overflowed by re-experiencing the effects of the substance, known as craving. Most of the times, these clinical symptoms act as negative reinforcement, which can be severe enough to induce a drug-relapse that greatly hampers the treatment.
TYPE OF STUDY randomized, double-blind, placebo-experimental. GENERAL PURPOSE To determine the efficacy of mirtazapine for the treatment of cocaine dependence. SPECIFIC OBJECTIVES 1) To evaluate the efficacy in the treatment of craving in individuals with cocaine dependence disorder treated with mirtazapine during acute withdrawal phase. 2) Determine the efficacy of reducing anxious depressive symptomatology (Crash) associated with acute withdrawal in subjects with cocaine dependence disorder treated with mirtazapine. 3) Evaluate the maintenance of abstinence in patients with cocaine dependence disorder treated with mirtazapine. 4) Determine the efficacy of mirtazapine in the treatment of subjects dependent on cocaine comorbid with major depressive disorder.
HYPOTHESIS For pharmacokinetics and pharmacodynamics mirtazapine contribute to the reduction in the intensity of withdrawal symptoms in cocaine dependent subjects by acting on the neurochemical circuitry involved in the reward-seeking behavior and has a prolonged effect anticraving. METHOD The attending physician outpatient identifies the Addiction Clinic of the National Institute of Psychiatry who meet the inclusion criteria and invite them to participate voluntarily. If patients accept, send them to the principal investigator for the start of the ratings. Demographics INSTRUMENTS, MINI structured interview, Anxiety and Depression Scale Beck Scale.
Detailed description
Evaluation. Evaluation of cocaine craving was assessed weekly through the Cocaine Craving Questionnaire (CCQ-G) (43-46). The CCQ-G measures the desire or urge level for drug consumption throughout the 45 Likert items established in the Questionnaire. The Likert scale consisted of seven options ranging from 1 to 7. Indicating from the lowest number (1) complete disagree of questions asked/item and the highest number (7) complete agreement of questions answered/item. CCQ-G items were written in past tense, with the intention that participants could report their cocaine craving status (level) during the previous week. Main items in the CCQ-G used to assess cocaine craving defined as factors were; a). Elements that denote intense cocaine craving (factor 1); b). Items that related to the anticipation of positive results (factor 2); c). Anticipation of relief from drug-withdrawal symptoms (factor 3); and d). Items that perceived a lack of control over cocaine consumption, denoting the intention and planning for cocaine consumption (factor 4).
Each week patient were assessed about their psychopathological status through the Symptom Check List 90 (SCL-90-R) (47-50). The SCL-90 evaluate the psychological degree of "distress" shown by a subject through 90 Likert-type reagents, ranging from 0 up to 4, and grouped into nine dimensions, which include, somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism.
Statistical Analysis.
Data were expressed, as mean ± SEM. To determinate the differences in score between groups over time, the data were then analyzed by a two-way repeated measures ANOVA with time (week) as the repeated measure. If there was a significant interaction between time and treatment, we then performed a Tukey's post-hoc test to detect significant differences between each one of the factors at each experimental phase. Comparisons between mean score obtained during each phase were analyzed by a two-way ANOVA (treatment x phase) followed by Tukey's test for post-hoc comparisons. The level of statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Experimental | Drug: Mirtazapine (REMERON, Schering-Plough-Organon)During the first and second phase of the study, subjects assigned to the control group received one tablet of placebo under daily basis, whereas the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, placebo group received same tablet under daily basis, whereas the mirtazapine group received 15 mg of mirtazapine. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Who can read and write. Meet the DSM IV TR criteria for substance dependence disorder (Snuff, cocaine, ethanol and polysubstance.). That meet the ratings.
Key exclusion criteria (1 listed)
- disorder subjects with a history of dependency that are not abstinent (³. 1 month). Subjects with a history of neurological diseases. Subjects with general medical illness (eg CVD, hypertension, DM). Subjects prior to the implementation of neurocognitive testing report having consumed coffee, tea, alcohol or smoked three hours conducting assessments. Subjects who take more than 3 prescription drugs. Those who report being too tired. Subjects who report not having made an effort to answer the tests.
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 |
|---|---|---|
| Mirtazapine (REMERON, Schering-Plough-Organon)Also: MIRDuring the first and second phase of the study,the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, the mirtazapine group received 15 mg of mirtazapine. | Drug | Mirtazapine |
Primary outcome
Evidence that Mirtazapine attenuates cocaine-craving.
Time frame: Four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2013.
- Background: PubMed 22221171Afshar M, Knapp CM, Sarid-Segal O, Devine E, Colaneri LS, Tozier L, Waters ME, Putnam MA, Ciraulo DA. The efficacy of mirtazapine in the treatment of cocaine dependence with comorbid depression. Am J Drug Alcohol Abuse. 2012 Mar;38(2):181-6. doi: 10.3109/00952990.2011.644002. Epub 2012 Jan 5.
- Background: PubMed 12487943Zueco Perez PL. [Mirtazapine in the treatment of cocaine-dependence in patients with methadone]. Actas Esp Psiquiatr. 2002 Nov-Dec;30(6):337-42. Spanish.
- Background: PubMed 22960395Graves SM, Rafeyan R, Watts J, Napier TC. Mirtazapine, and mirtazapine-like compounds as possible pharmacotherapy for substance abuse disorders: evidence from the bench and the bedside. Pharmacol Ther. 2012 Dec;136(3):343-53. doi: 10.1016/j.pharmthera.2012.08.013. Epub 2012 Aug 29.
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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.
Benito Antón-Palma, MD-PhD study director
National Institute of Psychiatry
Ricardo Nanni-Alvarado, Psychiatry principal investigator
National Institute of Psychiatry
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 (REMERON, Schering-Plough-Organon) in people with Drug-withdrawal. and Drug Abuse, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
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 1 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 24 Sep 2013. 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 Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evidence that Mirtazapine attenuates cocaine-craving. (time frame: Four years). 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 NCT01949571, which also lists 3 linked publications.
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 24 Sep 2013.