Cocaine Use Disorder Clinical Trial
Official title:
A Phase II, Double-Blind, Placebo-Controlled, Trial Of NS2359 For The Treatment of Cocaine Dependence
NCT number | NCT02798627 |
Other study ID # | 824109 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | October 2020 |
Verified date | May 2021 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
NS2359 attenuates the euphoria associated with cocaine use. In a manner parallel to cocaine, NS2359 blocks the reuptake of dopamine (DA), norepinephrine (NE), and serotonin (5HT) with nanomolar affinities at the 3 transporters. In primates NS2359 significantly attenuated cocaine self-administration. In several phase II clinical trials for major depressive disorder and adult attention deficit disorder, NS2359 did not cause euphoria. NS2359 exhibited no abuse potential in a human laboratory study comparing NS2359 with amphetamine. In a phase I human laboratory interaction study, NS2359 showed no toxicity after 20 or 40 mg of cocaine, but it attenuated the both the rewarding and cardiovascular effects of intravenous cocaine. On the basis of these promising studies, investigators propose a Phase II double-blind clinical trial of NS2359 in cocaine addiction (CA). The proposed trial will involve 100 CA subjects participating in an eight week trial, including a 1-week baseline and 8 weeks of NS2359 or placebo treatment. Four weeks after completing the medication phase, there will be one follow-up visit. Subjects will be randomly assigned to treatment with placebo or 2 mg NS2359 daily, with a possible decrease to 1 mg daily for adverse events. This dose range is selected on the basis of phase I and II evidence of tolerability and NS2359 plasma levels which were associated with blockade of cocaine reward. This project has the potential to identify the first effective pharmacotherapy for CA.
Status | Completed |
Enrollment | 55 |
Est. completion date | October 2020 |
Est. primary completion date | March 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Male and females, 18-65 years old. 2. Meets diagnostic criteria (DSM-V) for current diagnosis of cocaine use disorder, moderate to severe, by semi-structured interview. 3. In the past 30 days, used no less than $100-worth of cocaine 4. Speaks, understands, and prints in English. Exclusion Criteria: 1. Meets DSM-V criteria for substance use disorder, moderate to severe, for a substance other than cocaine, alcohol or nicotine. Subjects with comorbid alcohol use disorder will be accepted if their alcohol use disorder is not severe enough to require a medical alcohol detoxification. 2. Needs treatment with any psychoactive medications (with the exception of diphenhydramine or melatonin, if necessary, for sleep). 3. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder, or organic mental disorder. 4. Has another Axis I psychiatric disorder that in the opinion of the physician will interfere with completion of the study or place the patient at heightened risk through participation in the trial. 5. Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease. 6. Use of an investigational medication in the 30 days prior to randomization. 7. Is female and has a positive pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using effective contraception (if relevant). - |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Saniona, The Dana Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Number of Participants Who Achieved Abstinence From Cocaine During the Last Three Weeks of the Trial | Number of Participants Who Report no Cocaine Use and Have no Cocaine Positive Urine Drug Screens in the NS2359 Group Versus the Placebo Group Comparator During the Last Three Weeks of the Trial [ Time Frame: weeks 6,7.8 of the trial ] Number of subjects with cocaine abstinence as measured through three-times-weekly urine benzoylecgonine (BE) levels in urine drug screen (UDS) and self-reports of use from the Time Line Follow Back. UDS results and TLFB reports combined to yield weekly use/no-use indicators for each week of treatment. | 8 weeks | |
Secondary | Average Weekly Cocaine Craving Scores NS2359 Group Versus the Placebo Group Comparator [ Time Frame: Once Per Week in Weeks 2 Through 8 ] | As measured by average weekly scores for cocaine craving on the brief substance craving scale combining cocaine craving frequency, intensity and duration. Minimum value 0 maximum value 12 higher scores indicate worse craving. | 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03538548 -
Treatment Outcome in CBT for Cocaine Use
|
N/A | |
Recruiting |
NCT04994821 -
tDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study
|
Phase 2 | |
Not yet recruiting |
NCT06050304 -
CRACK-TARGET 1: ÉTUDE DESCRIPTIVE DE LA SENSIBILISATION COMPORTEMENTALE OBSERVÉE et ATTENTES
|
||
Completed |
NCT02233647 -
Phendimetrazine and Cocaine
|
Early Phase 1 | |
Completed |
NCT02239913 -
Topiramate-Phentermine Combinations for Cocaine Dependence
|
Phase 1 | |
Not yet recruiting |
NCT05974202 -
rTMS and Cognitive-behavioral Therapy for Cocaine Use Disorder
|
Phase 2 | |
Recruiting |
NCT04927143 -
Encouraging Abstinence Behavior in a Drug Epidemic
|
Phase 2 | |
Completed |
NCT03224546 -
Cocaine Use Reduction and Health
|
N/A | |
Recruiting |
NCT03656653 -
Imagery-based Coping for Cocaine Use Disorder
|
N/A | |
Completed |
NCT03348384 -
[11C]NOP-1A and Cocaine Use Disorders
|
Early Phase 1 | |
Recruiting |
NCT05019430 -
Cocaine and Zolmitriptan
|
Early Phase 1 | |
Recruiting |
NCT03344419 -
Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
|
Phase 3 | |
Recruiting |
NCT05507814 -
Temporal Window and Episodic Future Thinking in CUD
|
N/A | |
Active, not recruiting |
NCT03799341 -
Neurocognitive Factors in Substance Use Treatment Response: The Ways of Rewarding Abstinence Project
|
N/A | |
Completed |
NCT02785406 -
Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use
|
Phase 2 | |
Completed |
NCT02444208 -
A Feasibility Trial for Inhibitory-Control Training to Reduce Cocaine Use
|
N/A | |
Recruiting |
NCT05902819 -
Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories
|
N/A | |
Recruiting |
NCT05833529 -
Innovative Cognitive and Behavioral Psychotherapy for Cocaine Use Disorder
|
N/A | |
Recruiting |
NCT05521854 -
Contingency Management for Drug Use: Does Age Matter?
|
N/A | |
Completed |
NCT05557149 -
Virtual Reality Exposure and Respiratory Relaxation-Based Coping With Cocaine Craving in Cocaine Users
|
N/A |