Trial Of NS2359 For The Treatment of Cocaine Dependence
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|ClinicalTrials.gov Identifier: NCT02798627|
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : September 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Use Disorder||Drug: NS2359 Drug: placebo||Phase 2|
In this phase II randomized double-blind, placebo-controlled trial, 40 persons will be randomized to NS2359 and 40 to placebo. The primary hypothesis is: more NS2359-treated subjects (compared to placebo-treated subjects) will achieve 3 consecutive weeks of cocaine abstinence, as measured by urine benzoylecgonine (BE) assay, during the last three weeks of the trial. The study is 9 weeks: one week of screening, followed by an 8-week double-blind, placebo-controlled trial. All subjects will receive weekly cognitive behavioral therapy (CBT) to encourage abstinence during their 3 times weekly clinic visits. Investigators expect ~ 20% dropout rate, based on our recent CA clinical trials (eg, Kampman et al, 2015 and 2013), so 80 randomized patients will yield ~ 64 study completers. There will be a 1 month start-up period, followed by 20 months of recruitment for the study. The 1 month start-up period will allow for training of staff, preparation of study capsules, placement of study advertisements, etc. Penn IRB approval has been obtained. There will be a 2-month termination period to allow the final patients to complete the study. Data cleaning, statistical analyses and preparation of reports will be done in the final two months. Based on recent cocaine pharmacotherapy trials conducted by our team, monthly enrollment of ~4 CA participants (respondents to flyers and advertisements) is feasible.
Recruitment will occur at the University of Pennsylvania's Treatment Research Center (TRC), led by Kyle Kampman, MD, and Wade Berrettini, MD, PhD, Professors of Psychiatry at Penn. At the TRC, CA patients are respondents to advertisements for free treatment of CA. The ethnicity is 90% African-American, 9 % European-American, 70% male, mean age 47 (+/- 12).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Double-Blind, Placebo-Controlled, Trial Of NS2359 For The Treatment of Cocaine Dependence|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||July 2021|
The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
Placebo Comparator: placebo
Placebo pills matched to NS2359 pills will be given once daily. Patients with difficult adverse events at the 2 mg placebo will be allowed to reduce to 1 mg placebo once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.
Placebo pills identical in appearance to the NS2359 will be provided
- Trial Of NS2359 For The Treatment of Cocaine Dependence: urine drug screen for benzoylecgonine [ Time Frame: 8 weeks ]Urine samples will be provided by each participant every Monday, Wednesday and Friday for weeks 2-9. These urine samples will be assayed for benzoylecgonine, a cocaine metabolite. If a urine sample tests positive for BE during a week, that week will be reported as a cocaine use week. If all 3 samples test negative for BE, that week will be reported as an abstinent week.
- Trial Of NS2359 For The Treatment of Cocaine Dependence: alcohol intake assessment [ Time Frame: 8 weeks ]Alcohol intake will be assessed by asking each participant at each clinic visit to specify the number of alcohol drinks consumed each day since the most recent clinic visit. The number of drinks/day and the number of drinking days will be reported for each week for each participant.
- Trial Of NS2359 For The Treatment of Cocaine Dependence: tobacco use assessment [ Time Frame: 8 weeks ]Cigarettes smoked per day will be recorded for each participant at baseline and at weeks 5 and week 9, the end of the medication phase.
- Trial Of NS2359 For The Treatment of Cocaine Dependence: Treatment emergent adverse event assessment [ Time Frame: 8 weeks ]Participants will be asked about adverse events at each clinic visit. Expected adverse events include insomnia, anxiety, dizziness, dry mouth, tiredness. Adverse events will be reported as summary data across all participants for each adverse event, including estimates of severity and frequency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798627
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kyle Kampman, MD 215-222-3200 ext 109 firstname.lastname@example.org|
|Contact: Wade Berrettini, MD, PhD 2158980092 email@example.com|
|Principal Investigator:||Wade Berrettini, MD, PhD||University of Pennsylvania Perelman School of Medicine, Department of Psychiatry|