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 range18 Years – 65 Years

SexALL

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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.
✓. 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

What they're measuring

Stimulant use 1 month after leaving inpatient treatment (self-report)

Timeframe: 84 days

Stimulant use 1 month after leaving inpatient treatment (urine toxicology)

Timeframe: 84 days

Trial details

NCT IDNCT04553263

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-11

View on ClinicalTrials.gov More Stimulant Use trials