A Pilot Study of Candesartan as a Treatment for Cocaine Dependence

NCT01938664 | Terminated Phase 2 Results DMC

• 2 other identifiers: H-322415P50DA018197-09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if a drug called Candesartan will help to reduce use of cocaine.

Conditions

Cocaine Dependence

Keywords

cocaine; dependence; pharmacotherapy

Outcome Measures

Primary Outcomes (1)

• # of Participants With Presence of Cocaine Metabolites Via Urinalysis

  thrice weekly, baseline thru week 8

Secondary Outcomes (2)

• # of Participants Retained in Study

  8 weeks

• # of Participants With Adverse Events

  8 weeks

Study Arms (2)

Candesartan w Cognitive Behavior Therapy

EXPERIMENTAL

Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study.

Drug: Candesartan with CBT

Placebo w Cognitive Behavior Therapy

PLACEBO COMPARATOR

Sugar pill to mimic Candesartan for study duration. CBT optional thru study.

Other: Placebo with CBT

Interventions

Candesartan with CBT DRUG

8 mg, po (by mouth)

Also known as: atacand

Candesartan w Cognitive Behavior Therapy

Placebo with CBT OTHER

Placebo w Cognitive Behavior Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• 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.
• 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

You may not qualify if:

• 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 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
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

candesartan; candesartan cilexetil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Thomas Kosten, MD
• Organization: Baylor College of Medicine

kosten@bcm.edu

713-794-7032

Study Officials

• Thomas Kosten, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 4, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)