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Pharmacogenetic Trial of Doxazosin for Treatment of Cocaine Abuse
Phase 2 trial testing Doxazosin in Cocaine Dependence in 43 participants. Completed in 1 October 2017.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 1 April 2014 |
| Primary completion | 1 September 2017 |
| Estimated completion | 1 October 2017 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
Adults 18 to 64, any sex, with Cocaine Dependence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Over period of 12 weeks with 43 participants total (Doxazosin group = 22; Placebo group = 21), the overall percentage of cocaine positive urines per treatment group
| Group | Value | 95% CI |
|---|---|---|
| Doxazosin | 67.6 | |
| Placebo | 69 |
Time frame: Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Doxazosin | Placebo |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Dry mouth | General disorders | — | — |
| Lightheadedness | General disorders | — | — |
| Cold/Viral Illness | Infections and infestations | — | — |
| Stomach Pain/Indigestion | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Swelling | Immune system disorders | — | — |
| Erectile Dysfunction | Reproductive system and breast disorders | — | — |
| Allergies | Immune system disorders | — | — |
| Dizziness | General disorders | — | — |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Muscle twitching | General disorders | — | — |
| Numbness | Nervous system disorders | — | — |
| Increased Drug Craving | Psychiatric disorders | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — |
Data from ClinicalTrials.gov NCT01953432 adverse events section.
Cocaine use disorders affect approximately 1.5 million Americans annually. Currently, there are no US Food and Drug Administration approved medications for treatment of cocaine dependence; however, both animal and human studies suggest that medications affecting the noradrenergic system can reduce cocaine craving and use. The investigators will study the effect of doxazosin, an alpha-1 adrenergic antagonist, in reducing cocaine use and anxiety symptoms among cocaine-dependent individuals. In addition, the investigators will identify genetic subpopulations of participants who preferentially respond to the medication.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing