D-Serine for Cocaine Dependence Pilot

• Status: Withdrawn
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to collect pilot data on the efficacy of D-serine, relative to placebo, as a cocaine dependence treatment. Secondary objectives include evaluating D-serine, relative to placebo, on: 1. safety in treating cocaine-dependent adults and 2. tolerability.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theresa Winhusen
• Treatments: Cocaine

Criteria

Inclusion Criteria:

1. be 18 years of age or older

2. be able to understand the study, and having understood, provide written informed consent in English

3. meet DSM-IV-TR diagnostic criteria for current (within the last 12 months) dependence for cocaine,

4. have at least 1 positive urine BE specimen (> 300 ng/mL) during screening/baseline with a minimum of 3 urine samples tested if screening/baseline is completed within 7 days or a minimum of 4 urine samples tested if screening/baseline is completed during a period >7 days and ≤ 14 days

5. have a willingness to comply with all study procedures and medication instructions

6. be seeking treatment for cocaine dependence

7. weigh >101 and <340 pounds

8. if female and of child bearing potential, agree to use one of the following methods of birth control:

• oral contraceptives

• contraceptive patch

• barrier (diaphragm or condom)

• intrauterine contraceptive system

• levonorgestrel implant

• medroxyprogesterone acetate contraceptive injection

• complete abstinence from sexual intercourse

• hormonal vaginal contraceptive ring

Exclusion Criteria:

1. have current dependence, defined by DSM-IV-TR criteria, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiological dependence on alcohol requiring medical detoxification.

2. have been enrolled in a medication assisted treatment program for opioid dependence (e.g., methadone, buprenorphine) within 2 months of consent.

3. have a medical or psychiatric condition that, in the judgment of the study physician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to:

• significant renal disease or estimated Glomerular Filtration Rate (GFR) ≤ 60

• AIDS according to the current Centers for Disease Control (CDC) criteria for AIDS

• liver function tests greater than 3 times the upper limit of normal

• serum creatinine outside the normal range

4. have initiated or had a dose change in psychotropic medication in the 28 days prior to randomization if currently taking psychotropic medication

5. have a known or suspected hypersensitivity to D-serine

6. be pregnant or breastfeeding or plan to become pregnant

7. plan to take any of the following agents during the treatment phase:

• nonsteroidal anti-inflammatory drugs (NSAIDs)

• angiotensin-converting enzyme (ACE) inhibitors

• aminoglycosides

• angiotensin receptor blockers (ARBs)

• calcineurin inhibitors

8. be anyone who, in the judgment of the investigator, would not be expected to complete the study protocol (e.g., due to relocation from the clinic area, probable incarceration, etc.)

9. be a significant suicidal/homicidal risk