Relapse Prevention in Stimulant Use Disorder (NCT04553263) | Clinical Trial Compass
WithdrawnEarly Phase 1
Relapse Prevention in Stimulant Use Disorder
Stopped: Study never initiated
United States0Started 2023-06-11
Plain-language summary
The purpose of this study is to assess the relationship between bupropion, stimulant use and relapse, ADHD (Attention Deficit Hyperactivity Disorder), and measures of mood, drug craving, and inhibitory control in individuals enrolled in inpatient treatment for stimulant-use disorder with and without ADHD.
The experimenters hypothesize that Bupropion and Contrave (Bupropion/Naltrexone) will increase inhibitory control and decrease drug craving and depressive symptoms in recently abstinent stimulant users in inpatient treatment with effects greater than those seen in recently abstinent stimulant users completing inpatient treatment as usual. An additional hypothesis is that relapse rates after leaving inpatient treatment in the group receiving bupropion will be lower than those of the group completing inpatient treatment as usual.
The study design consists of four assessments of drug craving, inhibitory control, impulsive choice, and mood (depression and anxiety). The timepoints for these assessments include: A. baseline after entering treatment B. 2 weeks after starting drug C. 8 weeks after starting drug, and D. 1 month after leaving treatment. Following eligibility screening, 60 stimulant users will be enrolled in one of 3 groups. Group 1 Bupropion Active Group: 20 subjects will receive bupropion for 8 weeks during inpatient treatment. Group 2 Contrave Active Group: 20 subjects will receive Contrave for 8 weeks during inpatient treatment. Group 3 Control Group: 20 subjects enrolled in inpatient treatment will complete treatment as usual as well as the four assessments (A-D) described above but will not receive drug (convenience control). Half of the subjects in each group will be diagnosed with ADHD and half will not, for a total of 10 subjects per group with ADHD.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. English fluency (in order to provide informed consent and complete questionnaires)
. Age of 18-65 years inclusive
. Meeting DSM 5 criteria for Stimulant-use disorder
. Being 2-8 weeks abstinent from drugs of abuse other than nicotine (in cigarettes)
. Vital signs as follows: resting pulse between 50 and 95 bpm, blood pressures between 90-150 mm Hg systolic and 45-95 mm Hg diastolic (inclusive)
. Hematology and chemistry laboratory test results within normal (+/- 20%) limits and/or indicative of normal kidney function (estimated glomerular filtration rate ≥ 90 ml/min/1.73 m2) and/or not indicative of active disorder or infection.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stimulant use 1 month after leaving inpatient treatment (self-report)
Timeframe: 84 days
2
Stimulant use 1 month after leaving inpatient treatment (urine toxicology)
. Baseline ECG demonstrating normal conduction (including QTc) without clinically significant arrhythmias
. Absence of clinically significant contraindications for participation, in the judgment of the admitting physician and the principal investigator, assessed by a medical history and physical examination.
Exclusion criteria
. Age of \<18 or \>65 years.
. Current or past history of seizure disorder, including alcohol- or stimulant-related seizure, or significant family history of idiopathic seizure disorder or conditions that increase seizure risk (arteriovenous malformation, severe head injury, CNS tumor, CNS infection, stroke, anorexia nervosa or bulimia (current or prior diagnosis), and current use of drugs that lower seizure threshold
. Current severe substance use disorder assessed by the MINI on any psychoactive substance (e.g., opioids) other than methamphetamine, cocaine or nicotine, or have physiological dependence on alcohol or a sedative-hypnotic (e.g., a benzodiazepine) requiring medical detoxification, or undergoing abrupt discontinuation of ethanol or sedatives including anticonvulsants, barbiturates, or benzodiazepines
. Prior therapy with any opiate-substitutes (methadone, LAAM, buprenorphine) within 2 months of enrollment.
. Previous adverse reaction to Bupropion or Naltrexone.
. Current use of a. Bupropion, Naltrexone, opiates or opiate-substitutes, stimulants b.Any medications that directly affect dopaminergic or serotonergic neurotransmission in brain (i.e., SNRI, MAO-I, TCA) c. Any neuroleptic agent d. Systemic corticosteroids, Xanthines (i.e., theophylline) e. Sympathomimetics f. Antiretrovirals (i.e., nelfinavir, ritonavir and efavirenz) g. Linezolid or IV methylene blue h. Warfarin
. MAO-I use in the 2 weeks before enrollment
. Disease or injury preventing use of both eyes and ability to complete computer tasks assessing cognitive function (e.g. glaucoma, colorblindness)