Cocaine AddictionPhase 4NCT03018236
Effect of N-acetylcysteine on Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
A Phase 4 study testing Alcohol N-acetylcysteine and Cocaine N-acetylcysteine in people with Cocaine Addiction and Alcohol Addiction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cocaine Addiction, Alcohol Addiction
- What is being tested?
- Alcohol N-acetylcysteine and Cocaine N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Dec 2018
- Phase
- Phase 4
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic of Alcohol or Cocaine Use Disorder
- Seven days of inpatient treatment in an addiction treatment specialized unit
Who cannot join
- Another Substance Use Disorder (exception: tobacco)
- Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
- History of asthma or convulsions medication use
- Recent use (<14 days) of any medication that could interfere with the study medication
- History of anaphylactic reactions with the study medication
- Suicide risk
Show all 9Show fewer
- Inability to understand the informed consent form or to comply with the study requirements
- Any severe neuropsychiatric condition, not caused by the substance use, that requires specific medication treatments and could interfere with the study development, in the investigators opinion (for instance: dementia, schizophrenia or other psychoses, multiple sclerosis, severe depression, stroke, epilepsy, bipolar disorder)
- Failing to complete the screening procedures prior to the study first week
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre - Unidade Alvaro Alvim
Porto Alegre, Rio Grande do Sul, 90420-020
Thiago C Hartmann, MsC, +55 51 3359 6476, hartmann321@yahoo.com.br
About this study
Official title: The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.
Read the detailed description
N-acetylcysteine acts replenishing the human body glutathione storages. Glutathione is an important antioxidant agent, and also modulates the N-methyl-D-aspartate (NMDA) glutamatergic receptor. Glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. N-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space.
N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders.
This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs Placebo.
- Conditions
- Cocaine Addiction, Alcohol Addiction
- Being tested
- Alcohol N-acetylcysteine, Alcohol Placebo, Cocaine N-acetylcysteine, Cocaine Placebo
- Keywords
- cocaine, alcohol, substance use disorders, addiction, N-acetylcysteine, randomized controlled trial
- Medical subject headings
- Cocaine-Related Disorders, Alcoholism, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol N-acetylcysteineDrug
Also called NAC
1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
Alcohol PlaceboDrug
Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
Cocaine N-acetylcysteineDrug
Also called NAC
1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
Cocaine PlaceboDrug
Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
| Study group | Role | What they receive |
|---|---|---|
| Alcohol N-acetylcysteine | Experimental | 600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks Receives: Drug: Alcohol N-acetylcysteine |
| Alcohol Placebo | Placebo comparator | A placebo capsule matching color and smell of the active medication Receives: Drug: Alcohol Placebo |
| Cocaine N-acetylcysteine | Experimental | 600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks Receives: Drug: Cocaine N-acetylcysteine |
| Cocaine Placebo | Placebo comparator | A placebo capsule matching color and smell of the active medication Receives: Drug: Cocaine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who attended all study appointments
Completers (i.e. subjects who attended all study appointments) vs non-completers
Measured: 8 weeks
Secondary outcomes (16)
Abstinence by urine
Amount of positive urine tests for cocaine users
Measured: 8 weeks
Abstinence by breathalyzer
Amount of positive breathalyzer tests for alcohol users
Measured: 8 weeks
Abstinence by self report
Timeline Followback Method
Measured: 8 weeks
Days of inpatient treatment
The difference (if any) between placebo and intervention groups in the amount of inpatient treatment days.
Measured: Up to 4 weeks
Change in scores of CGI
Differences in scores of the Clinical Global Impression (CGI)
Measured: 8 weeks
Change in scores of FAST
Differences in scores of the Functioning Assessment Short Test (FAST).
Measured: 8 weeks
Depressive symptoms
Differences in scores of the Beck Depression Inventory (BDI)
Measured: 8 weeks
Anxiety symptoms
Differences in scores of the Beck Anxiety Inventory (BAI)
Measured: 8 weeks
BDNF
Differences between groups regarding dosage of Brain Derived Neurotrophic Factor (BDNF)
Measured: 8 weeks
GSSG
Differences between groups regarding dosage of Oxidized Glutathione (GSSG)
Measured: 8 weeks
GSH
Differences between groups regarding dosage of Glutathione (GSH)
Measured: 8 weeks
GPx
Differences between groups regarding dosage of Glutathione Peroxidase (GPx)
Measured: 8 weeks
CAT
Differences between groups regarding dosage of Catalase (CAT)
Measured: 8 weeks
TBARS
Differences between groups regarding dosage of Thiobarbituric Acid Reactive Substances (TBARS)
Measured: 8 weeks
SOD
Differences between groups regarding dosage of Superoxide Dismutase (SOD)
Measured: 8 weeks
Carbonyl
Differences between groups regarding dosage of Carbonyl
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for Cocaine AddictionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Secretaria Nacional de Políticas sobre Drogas (SENAD)
- Responsible party
- Sponsor
- Investigators
- Lisia von Diemen, PhD, Study chair, Federal University of Rio Grande do Sul (UFRGS)Flavio Pechansky, PhD, Principal investigator, Federal University of Rio Grande do Sul (UFRGS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018236
- Sponsor's protocol ID
- 150488
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Agrawal A, Verweij KJ, Gillespie NA, Heath AC, Lessov-Schlaggar CN, Martin NG, Nelson EC, Slutske WS, Whitfield JB, Lynskey MT. The genetics of addiction-a translational perspective. Transl Psychiatry. 2012 Jul 17;2(7):e140. doi: 10.1038/tp.2012.54.
PubMed 22806211Andreazza AC, Frey BN, Valvassori SS, Zanotto C, Gomes KM, Comim CM, Cassini C, Stertz L, Ribeiro LC, Quevedo J, Kapczinski F, Berk M, Goncalves CA. DNA damage in rats after treatment with methylphenidate. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Aug 15;31(6):1282-8. doi: 10.1016/j.pnpbp.2007.05.012. Epub 2007 Jun 2.
PubMed 17614179Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F, Bouvard V, Altieri A, Cogliano V; WHO International Agency for Research on Cancer Monograph Working Group. Carcinogenicity of alcoholic beverages. Lancet Oncol. 2007 Apr;8(4):292-3. doi: 10.1016/s1470-2045(07)70099-2. No abstract available.
PubMed 17431955Baker DA, McFarland K, Lake RW, Shen H, Toda S, Kalivas PW. N-acetyl cysteine-induced blockade of cocaine-induced reinstatement. Ann N Y Acad Sci. 2003 Nov;1003:349-51. doi: 10.1196/annals.1300.023. No abstract available.
PubMed 14684458Berk M, Malhi GS, Gray LJ, Dean OM. The promise of N-acetylcysteine in neuropsychiatry. Trends Pharmacol Sci. 2013 Mar;34(3):167-77. doi: 10.1016/j.tips.2013.01.001. Epub 2013 Jan 29.
PubMed 23369637Bibel M, Barde YA. Neurotrophins: key regulators of cell fate and cell shape in the vertebrate nervous system. Genes Dev. 2000 Dec 1;14(23):2919-37. doi: 10.1101/gad.841400. No abstract available.
PubMed 11114882Calado RT, Young NS. Telomere diseases. N Engl J Med. 2009 Dec 10;361(24):2353-65. doi: 10.1056/NEJMra0903373. No abstract available.
PubMed 20007561Chen CH, Pan CH, Chen CC, Huang MC. Increased oxidative DNA damage in patients with alcohol dependence and its correlation with alcohol withdrawal severity. Alcohol Clin Exp Res. 2011 Feb;35(2):338-44. doi: 10.1111/j.1530-0277.2010.01349.x. Epub 2010 Nov 10.
PubMed 21070251Corominas-Roso M, Roncero C, Daigre C, Grau-Lopez L, Ros-Cucurull E, Rodriguez-Cintas L, Sanchez-Mora C, Lopez MV, Ribases M, Casas M. Changes in brain-derived neurotrophic factor (BDNF) during abstinence could be associated with relapse in cocaine-dependent patients. Psychiatry Res. 2015 Feb 28;225(3):309-14. doi: 10.1016/j.psychres.2014.12.019. Epub 2014 Dec 20.
PubMed 25592977Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.
PubMed 21848960Cross CE, Valacchi G, Schock B, Wilson M, Weber S, Eiserich J, van der Vliet A. Environmental oxidant pollutant effects on biologic systems: a focus on micronutrient antioxidant-oxidant interactions. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 2):S44-50. doi: 10.1164/rccm.2206015.
PubMed 12471088Davis MI. Ethanol-BDNF interactions: still more questions than answers. Pharmacol Ther. 2008 Apr;118(1):36-57. doi: 10.1016/j.pharmthera.2008.01.003. Epub 2008 Feb 2.
PubMed 18394710Dean O, Giorlando F, Berk M. N-acetylcysteine in psychiatry: current therapeutic evidence and potential mechanisms of action. J Psychiatry Neurosci. 2011 Mar;36(2):78-86. doi: 10.1503/jpn.100057.
PubMed 21118657Degenhardt L, Singleton J, Calabria B, McLaren J, Kerr T, Mehta S, Kirk G, Hall WD. Mortality among cocaine users: a systematic review of cohort studies. Drug Alcohol Depend. 2011 Jan 15;113(2-3):88-95. doi: 10.1016/j.drugalcdep.2010.07.026. Epub 2010 Sep 15.
PubMed 20828942Ersche KD, Jones PS, Williams GB, Robbins TW, Bullmore ET. Cocaine dependence: a fast-track for brain ageing? Mol Psychiatry. 2013 Feb;18(2):134-5. doi: 10.1038/mp.2012.31. Epub 2012 Apr 24. No abstract available.
PubMed 22525488
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of N-acetylcysteine (NAC) on Treatment of Alcohol and Cocaine Use Disorders: A Double-Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03018236
- Acronym / sponsor ID
- 150488
- Conditions
- Cocaine Addiction, Alcohol Addiction
- Keywords
- cocaine, alcohol, substance use disorders, addiction, N-acetylcysteine, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Secretaria Nacional de Políticas sobre Drogas (SENAD)
- Study start
- Jan 2017
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Jan 2017 (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.
This study evaluates the use of N-acetylcysteine in the treatment of alcohol and cocaine use disorders. Alcohol users will be split in two groups, one will receive the active N-acetylcysteine and the other placebo. The same division will occur with cocaine users. The effects of N-acetylcysteine in adherence, abstinence, psychiatric symptoms and stress biomarkers will be evaluated.
Detailed description
N-acetylcysteine acts replenishing the human body glutathione storages. Glutathione is an important antioxidant agent, and also modulates the N-methyl-D-aspartate (NMDA) glutamatergic receptor. Glutamate has been associated with the neuroadaptation related to substance use disorders, and thus it is considered a potential target for pharmacological interventions regarding these disorders. N-acetylcysteine also interacts with the cystine-glutamate antiporter on astrocytes hence increasing glutamate release into the extracellular space.
N-acetylcysteine effects and its implications in the addiction disorders have been studied initially with animal models. Glutamate levels normalization through N-acetylcysteine reduced compulsive drug self-administration and drug-seeking behavior in mice. In addition, there are promising results also with human subjects, showing benefits for cocaine, alcohol and cannabis use disorders.
This study consists of a randomized, double-blind, placebo controlled trial with four arms: alcohol users divided into NAC vs Placebo and cocaine users divided into NAC vs Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alcohol N-acetylcysteine | Experimental | Drug: Alcohol N-acetylcysteine600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks |
| Alcohol Placebo | Placebo comparator | Drug: Alcohol PlaceboA placebo capsule matching color and smell of the active medication |
| Cocaine N-acetylcysteine | Experimental | Drug: Cocaine N-acetylcysteine600 mg N-acetylcysteine capsule by mouth, every 12 hours for 8 weeks |
| Cocaine Placebo | Placebo comparator | Drug: Cocaine PlaceboA placebo capsule matching color and smell of the active medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnostic of Alcohol or Cocaine Use Disorder
- Seven days of inpatient treatment in an addiction treatment specialized unit
Key exclusion criteria (9 listed)
- Another Substance Use Disorder (exception: tobacco)
- Severe medical conditions (cardiac, renal or hepatic), that preclude subject participation
- History of asthma or convulsions medication use
- Recent use (<14 days) of any medication that could interfere with the study medication
- History of anaphylactic reactions with the study medication
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 |
|---|---|---|
| Alcohol N-acetylcysteineAlso: NAC1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder | Drug | Alcohol N-acetylcysteine |
| Alcohol PlaceboFlour pills looking exactly the same as the active compound, for subjects with alcohol use disorder | Drug | Alcohol Placebo |
| Cocaine N-acetylcysteineAlso: NAC1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder | Drug | Cocaine N-acetylcysteine |
| Cocaine PlaceboFlour pills looking exactly the same as the active compound, for subjects with cocaine use disorder | Drug | Cocaine Placebo |
Primary outcome
Number of participants who attended all study appointments
Time frame: 8 weeks
Completers (i.e. subjects who attended all study appointments) vs non-completers
16 secondary outcomes
Abstinence by urine
Time frame: 8 weeks
Abstinence by breathalyzer
Time frame: 8 weeks
Abstinence by self report
Time frame: 8 weeks
Days of inpatient treatment
Time frame: Up to 4 weeks
Change in scores of CGI
Time frame: 8 weeks
Change in scores of FAST
Time frame: 8 weeks
Depressive symptoms
Time frame: 8 weeks
Anxiety symptoms
Time frame: 8 weeks
BDNF
Time frame: 8 weeks
GSSG
Time frame: 8 weeks
GSH
Time frame: 8 weeks
GPx
Time frame: 8 weeks
CAT
Time frame: 8 weeks
TBARS
Time frame: 8 weeks
SOD
Time frame: 8 weeks
Carbonyl
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Background: PubMed 22806211Agrawal A, Verweij KJ, Gillespie NA, Heath AC, Lessov-Schlaggar CN, Martin NG, Nelson EC, Slutske WS, Whitfield JB, Lynskey MT. The genetics of addiction-a translational perspective. Transl Psychiatry. 2012 Jul 17;2(7):e140. doi: 10.1038/tp.2012.54.
- Background: PubMed 17614179Andreazza AC, Frey BN, Valvassori SS, Zanotto C, Gomes KM, Comim CM, Cassini C, Stertz L, Ribeiro LC, Quevedo J, Kapczinski F, Berk M, Goncalves CA. DNA damage in rats after treatment with methylphenidate. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Aug 15;31(6):1282-8. doi: 10.1016/j.pnpbp.2007.05.012. Epub 2007 Jun 2.
- Background: PubMed 17431955Baan R, Straif K, Grosse Y, Secretan B, El Ghissassi F, Bouvard V, Altieri A, Cogliano V; WHO International Agency for Research on Cancer Monograph Working Group. Carcinogenicity of alcoholic beverages. Lancet Oncol. 2007 Apr;8(4):292-3. doi: 10.1016/s1470-2045(07)70099-2. No abstract available.
- Background: PubMed 14684458Baker DA, McFarland K, Lake RW, Shen H, Toda S, Kalivas PW. N-acetyl cysteine-induced blockade of cocaine-induced reinstatement. Ann N Y Acad Sci. 2003 Nov;1003:349-51. doi: 10.1196/annals.1300.023. No abstract available.
- Background: PubMed 23369637Berk M, Malhi GS, Gray LJ, Dean OM. The promise of N-acetylcysteine in neuropsychiatry. Trends Pharmacol Sci. 2013 Mar;34(3):167-77. doi: 10.1016/j.tips.2013.01.001. Epub 2013 Jan 29.
- Background: PubMed 11114882Bibel M, Barde YA. Neurotrophins: key regulators of cell fate and cell shape in the vertebrate nervous system. Genes Dev. 2000 Dec 1;14(23):2919-37. doi: 10.1101/gad.841400. No abstract available.
- Background: PubMed 20007561Calado RT, Young NS. Telomere diseases. N Engl J Med. 2009 Dec 10;361(24):2353-65. doi: 10.1056/NEJMra0903373. No abstract available.
- Background: PubMed 21070251Chen CH, Pan CH, Chen CC, Huang MC. Increased oxidative DNA damage in patients with alcohol dependence and its correlation with alcohol withdrawal severity. Alcohol Clin Exp Res. 2011 Feb;35(2):338-44. doi: 10.1111/j.1530-0277.2010.01349.x. Epub 2010 Nov 10.
- Background: PubMed 25592977Corominas-Roso M, Roncero C, Daigre C, Grau-Lopez L, Ros-Cucurull E, Rodriguez-Cintas L, Sanchez-Mora C, Lopez MV, Ribases M, Casas M. Changes in brain-derived neurotrophic factor (BDNF) during abstinence could be associated with relapse in cocaine-dependent patients. Psychiatry Res. 2015 Feb 28;225(3):309-14. doi: 10.1016/j.psychres.2014.12.019. Epub 2014 Dec 20.
- Background: PubMed 21848960Costa MA, Girard M, Dalmay F, Malauzat D. Brain-derived neurotrophic factor serum levels in alcohol-dependent subjects 6 months after alcohol withdrawal. Alcohol Clin Exp Res. 2011 Nov;35(11):1966-73. doi: 10.1111/j.1530-0277.2011.01548.x. Epub 2011 Aug 16.
- Background: PubMed 12471088Cross CE, Valacchi G, Schock B, Wilson M, Weber S, Eiserich J, van der Vliet A. Environmental oxidant pollutant effects on biologic systems: a focus on micronutrient antioxidant-oxidant interactions. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 2):S44-50. doi: 10.1164/rccm.2206015.
- Background: PubMed 18394710Davis MI. Ethanol-BDNF interactions: still more questions than answers. Pharmacol Ther. 2008 Apr;118(1):36-57. doi: 10.1016/j.pharmthera.2008.01.003. Epub 2008 Feb 2.
- Individual participant dataSharing planned: Undecided
Related trials for Cocaine Addiction
Recruiting
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
Cocaine Use, Cocaine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Transcranial Direct Current Stimulation (tDCS) for Treatment of Substance Use Disorder
Cocaine Use Disorder, Cocaine Dependence
Active, not recruitingEarly Phase 1
Targeting Drug Memories With Methylphenidate
Substance Use Disorder, Cocaine Use Disorder
RecruitingPhase 1
Safety Study of a Disrupted Adenovirus (Ad) Serotype Cocaine Vaccine for Cocaine-dependent Individuals
Cocaine Dependence
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.
Lisia von Diemen, PhD study chair
Federal University of Rio Grande do Sul (UFRGS)
Flavio Pechansky, PhD principal investigator
Federal University of Rio Grande do Sul (UFRGS)
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 Alcohol N-acetylcysteine and Cocaine N-acetylcysteine in people with Cocaine Addiction and Alcohol Addiction, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 9 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: status not confirmed, as of the sponsor's last update on 24 Jan 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisia von Diemen, PhD (+55 51 3359 6471, lisiavd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who attended all study appointments (time frame: 8 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 NCT03018236, which also lists 71 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 Jan 2017.