Cocaine DependencePhase 2NCT01938664
A Pilot Study of Candesartan as a Treatment for Cocaine Dependence
A Phase 2 study testing Candesartan with CBT in people with Cocaine Dependence, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to see if a drug called Candesartan will help to reduce use of cocaine. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Candesartan with CBT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2016
- 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
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible for study entry, all subjects must satisfy the following criteria:
- Age 18 to 64 years inclusive;
- Females either must be of non-child bearing potential (i.e., surgically sterilized or postmenopausal) or must be using adequate contraception, have a negative pregnancy test, and must agree to continue to use such precautions for the duration of the study.
- Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV-TR) criteria for a principal diagnosis of cocaine dependence as confirmed by the MINI and/or as per PI/study investigator's examination of the patient during screening. (Per DSM-IV-TR, principal diagnosis is the condition that is the primary target of treatment at the time of presentation);
- Motivated to discontinue or reduce cocaine use during the period of the study, as evidenced both by the judgment of the Investigator or designee and by the subject's compliance level with the requirement for attendance at clinic visits such that the urine sample requirements for inclusion criteria #6 is fully met;
- Has a positive pattern of cocaine usage as determined by provision of at least one cocaine positive urine sample (benzoylecgonine (BE) level at least 300 ng/ml) during the screening period; typically conducted over a 7-14 day period.
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- In good general health as determined by self-reported and/or computer-based medical history, general clinical examination, and laboratory tests;
- Has provided written informed consent.
- Are cooperative, willing and able to participate and adhere to the protocol requirements
Who cannot join
- Subjects will be excluded from the study if one or more of the following statements are applicable:
- Subject is taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Lexxel, in Vaseretic), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); lithium (Eskalith Controlled-Release, Eskalith, Lithobid);
- Subject is on psychotropic medications, an MAOI, or an opiate antagonist;
- Subject is currently taking a dopaminergic, dopamine-blocking, dopamine-modulating, or other central dopamine-altering drug (e.g., antipsychotic drugs); a monoamine oxidase inhibitor (MAOI); or an opiate antagonist;
- Subject has an unstable medical, neurologic, or psychiatric illness that would interfere with the subject's safety, ability to participate in the study, or the interpretability of data. Subjects who meet the DSM-IV-R criteria for psychosis, schizophrenia, bipolar disorder or clinically significant suicidal ideation as assessed by the PI/study investigator and/or the MINI will be excluded. Subjects who have been taking stable doses of antidepressants for at least 3 months at the time the consent is signed will be allowed onto the study unless those antidepressants are of the types specified under exclusion criteria #3,above;
- Subject is dependent on benzodiazepines, barbiturates, amphetamines, opiates (including methadone or buprenorphine maintenance treatment) according to the DSM-IV-R and as assessed by the PI/study investigator and/or the MINI; 6
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- Subject is, in the investigator's opinion, at risk of requiring medical detoxification for alcohol dependence during the study;
- Subject has participated in another clinical trial or received any other investigational compound within 7 days prior to being randomized into this study;
- Significant medical conditions (e.g., major cardiovascular, renal, endocrine, hepatic disorders, immunosuppressive disorders) such as abnormal liver function (with laboratory findings of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) greater than three times normal), hypotension, hypertension, a current cardiac condition, and those having a high risk of cardiovascular disease, seizure disorder, or another significant underlying medical condition which would contraindicate Candesartan treatment;
- Upon review of a compilation of screening data, at the discretion of the PI/study investigator, a participant may be excluded from the study if they test positive during the screening process for any substance other than cocaine or marijuana;
- Female subjects with a positive pregnancy test, lactating mothers, women refusing to agree to pregnancy tests during the study, women who are planning to become pregnant during the period of the trial or women of child-bearing potential who refuse to agree to use adequate contraception during the study. Acceptable contraceptive methods are oral or parenteral hormonal contraceptives, intrauterine device (IUD), or barrier and spermicide, but not abstinence; OR Male subjects refusing to agree to use adequate contraception during the study, or males who are part of a couple planning to become pregnant during the period of the trial;
- Any other factor that per the Investigator/designee would make the subject unsafe or unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Pilot Study of Candesartan: An Angiotensin Receptor Blocker as a Treatment for Cocaine Dependence
The purpose of this study is to see if a drug called Candesartan will help to reduce use of cocaine.
Read the detailed description
The noradrenergic system may play an important role in cocaine addiction in humans. Angiotensin II (Ang II) is known to enhance noradrenergic activity, which contributes to effects on blood pressure and sympathetic nervous system responses to stress. Inhibition of Ang II has been shown to reduce cravings for stimulants, including cocaine and methamphetamine.
This clinical trial among 75 cocaine-dependent subjects is designed to test the efficacy of the Angiotensin II receptor antagonist, Candesartan, for treatment of cocaine dependence. The results of this study will provide medical safety and efficacy data, and will guide future pharmacotherapy trials using this class of medications for cocaine addiction.
This 8-week trial includes a 1-week titration of the medication and 7-weeks of full dose medication (weeks 2-8), with all subjects receiving the active agent.
At the conclusion of the trial, subjects who wish to be referred to an appropriate treatment program or treatment research program will be assisted with a referral.
- Conditions
- Cocaine Dependence
- Being tested
- Candesartan with CBT, Placebo with CBT
- Keywords
- cocaine, dependence, pharmacotherapy
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candesartan with CBTDrug
Also called atacand
8 mg, po (by mouth)
Placebo with CBTOther
| Study group | Role | What they receive |
|---|---|---|
| Candesartan w Cognitive Behavior Therapy | Experimental | Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. Receives: Drug: Candesartan with CBT |
| Placebo w Cognitive Behavior Therapy | Placebo comparator | Sugar pill to mimic Candesartan for study duration. CBT optional thru study. Receives: Other: Placebo with CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
# of Participants With Presence of Cocaine Metabolites Via Urinalysis
Measured: thrice weekly, baseline thru week 8
Secondary outcomes (2)
# of Participants Retained in Study
Measured: 8 weeks
# of Participants With Adverse Events
Candesartan will be well tolerated without significant side effects.
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 posted10 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2016
- Study completionJul 2016
Why it stopped: Results of interim efficacy analysis showed results were not promising.
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 Baylor College of MedicineThe 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, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Thomas R. Kosten, MD, Baylor College of Medicine
- Investigators
- Thomas Kosten, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938664
- Sponsor's protocol ID
- H-32241
- Other IDs
- 5P50DA018197-09
- Status last verified
- Aug 2019
- First submitted
- 5 Sep 2013
- Last updated
- 4 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Candesartan: An Angiotensin Receptor Blocker as a Treatment for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01938664
- Acronym / sponsor ID
- H-32241
- Conditions
- Cocaine Dependence
- Keywords
- cocaine, dependence, pharmacotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of interim efficacy analysis showed results were not promising.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 26 Aug 2019
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 see if a drug called Candesartan will help to reduce use of cocaine.
Detailed description
The noradrenergic system may play an important role in cocaine addiction in humans. Angiotensin II (Ang II) is known to enhance noradrenergic activity, which contributes to effects on blood pressure and sympathetic nervous system responses to stress. Inhibition of Ang II has been shown to reduce cravings for stimulants, including cocaine and methamphetamine.
This clinical trial among 75 cocaine-dependent subjects is designed to test the efficacy of the Angiotensin II receptor antagonist, Candesartan, for treatment of cocaine dependence. The results of this study will provide medical safety and efficacy data, and will guide future pharmacotherapy trials using this class of medications for cocaine addiction.
This 8-week trial includes a 1-week titration of the medication and 7-weeks of full dose medication (weeks 2-8), with all subjects receiving the active agent.
At the conclusion of the trial, subjects who wish to be referred to an appropriate treatment program or treatment research program will be assisted with a referral.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan w Cognitive Behavior Therapy | Experimental | Drug: Candesartan with CBTTitration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. |
| Placebo w Cognitive Behavior Therapy | Placebo comparator | Other: Placebo with CBTSugar pill to mimic Candesartan for study duration. CBT optional thru study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18 to 64 years inclusive;
- Females either must be of non-child bearing potential (i.e., surgically sterilized or postmenopausal) or must be using adequate contraception, have a negative pregnancy test, and must agree to continue to use such precautions for the duration of the study.
- Meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV-TR) criteria for a principal diagnosis of cocaine dependence as confirmed by the MINI and/or as per PI/study investigator's examination of the patient during screening. (Per DSM-IV-TR, principal diagnosis is the condition that is the primary target of treatment at the time of presentation);
- Motivated to discontinue or reduce cocaine use during the period of the study, as evidenced both by the judgment of the Investigator or designee and by the subject's compliance level with the requirement for attendance at clinic visits such that the urine sample requirements for inclusion criteria #6 is fully met;
- Has a positive pattern of cocaine usage as determined by provision of at least one cocaine positive urine sample (benzoylecgonine (BE) level at least 300 ng/ml) during the screening period; typically conducted over a 7-14 day period.
Key exclusion criteria (12 listed)
- Subjects will be excluded from the study if one or more of the following statements are applicable:
- Subject is taking angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Lexxel, in Vaseretic), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); lithium (Eskalith Controlled-Release, Eskalith, Lithobid);
- Subject is on psychotropic medications, an MAOI, or an opiate antagonist;
- Subject is currently taking a dopaminergic, dopamine-blocking, dopamine-modulating, or other central dopamine-altering drug (e.g., antipsychotic drugs); a monoamine oxidase inhibitor (MAOI); or an opiate antagonist;
- Subject has an unstable medical, neurologic, or psychiatric illness that would interfere with the subject's safety, ability to participate in the study, or the interpretability of data. Subjects who meet the DSM-IV-R criteria for psychosis, schizophrenia, bipolar disorder or clinically significant suicidal ideation as assessed by the PI/study investigator and/or the MINI will be excluded. Subjects who have been taking stable doses of antidepressants for at least 3 months at the time the consent is signed will be allowed onto the study unless those antidepressants are of the types specified under exclusion criteria #3,above;
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 |
|---|---|---|
| Candesartan with CBTAlso: atacand8 mg, po (by mouth) | Drug | Candesartan w Cognitive Behavior Therapy |
| Placebo with CBT | Other | Placebo w Cognitive Behavior Therapy |
Primary outcome
# of Participants With Presence of Cocaine Metabolites Via Urinalysis
Time frame: thrice weekly, baseline thru week 8
2 secondary outcomes
# of Participants Retained in Study
Time frame: 8 weeks
# of Participants With Adverse Events
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- 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.
Thomas Kosten, MD principal investigator
Baylor College of Medicine
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 Candesartan with CBT in people with Cocaine Dependence, run by Baylor College of Medicine 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Sep 2019. 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 26 Aug 2019). 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?
# of Participants With Presence of Cocaine Metabolites Via Urinalysis (time frame: thrice weekly, baseline thru week 8). 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 4 Sep 2019.