A Phase 2 interventional study of Atomoxetine and Placebo in Alcohol Use Disorder, sponsored by Brown University. Completed at 1 site in United States. Open to participants aged 14 Years to 20 Years. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Brown University · Phase 2, Interventional, and Treatment
The primary objectives of this study are twofold. The first primary objective is to evaluate the feasibility, acceptability, and tolerability of atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) as compared to placebo for 6 weeks plus a psychosocial platform comprised of motivational enhancement therapy and cognitive behavioral therapy (MET-CBT) among adolescents (ages 14 to 19 years) with alcohol use disorder as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). The second primary objective is to leverage a human laboratory paradigm and ecological momentary assessment (EMA) methods to evaluate the effects of atomoxetine on intermediate phenotypes associated with alcohol use and outcomes in clinical trials.
This proof-of-concept study is a double-blind, randomized, placebo-controlled, parallel-group, single-site study designed to assess the feasibility, acceptability, and tolerability of atomoxetine for alcohol use disorder among adolescents ages 14 to 19 years. In addition, this project will test the effects of atomoxetine, as compared with placebo, on responses to in vivo alcohol cue exposure in the human laboratory setting. After obtaining consent/parent permission/assent, youth and, if younger than 18 years, their parent will complete a medical history interview to screen for eligibility. Youth will also be screened for eligibility. If eligible for the study, participants will be randomized in an approximate 1:1 ratio (targeting 21 participants per group - 42 participants total) to either atomoxetine or placebo for 6 weeks. Atomoxetine will be dosed at 40 mg/day for three days then increased to the maintenance dose of 80 mg (active) taken orally once daily (QD) for an additional 5.5 weeks. Participants randomized to the placebo condition will be given an equal number of visually matched capsules.
Participants will be seen in the clinic at the in-person screening appointment, the randomization/baseline session, and at 8 other times during the study. Three follow-up telephone interviews will occur at 2 weeks and three and six months after the last in-clinic visit. At the randomization/baseline visit and after 4 weeks of investigational product administration (i.e., Study Week 7), participants will undergo a human laboratory paradigm (i.e., alcohol cue reactivity assessment). In addition, participants will complete EMA on a smartphone throughout the day in their daily lives.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 42 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Brown University is the lead sponsor of 282 studies on the registry; 42 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
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Exclusion Criteria:
Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial
Drug: Atomoxetine
Identical matching placebo capsules
Drug: Placebo
Participants randomized to receive the study medication, atomoxetine (brand name: Straterra) for 6-weeks (40 mg/day for 3 days then 80 mg/day thereafter). A comparator group will receive placebo (sugar pills).
Also known as: Strattera
Matching placebo (sugar pill)
Completion Rates
Number and percentage of youth who complete the active medication phase will determine feasibility.
Time frame: 6-week active treatment phase
Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8
The Client Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8 to 32 (higher scores indicate higher satisfaction), will determine acceptability. Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the CSQ-8 is ≥ 80%.
Time frame: 6-week active treatment phase
Alcohol Craving
The primary measure of alcohol craving is the number and percentage of participants who report any level of alcohol craving during a laboratory alcohol-cue exposure paradigm using the following single item: How strong is your craving to drink alcohol? Scores range from 0 (None) to 20 (Extremely Strong). Individuals who endorse any level of alcohol craving (e.g., \> 1) are considered to experience craving. Individuals who do not report any alcohol craving (e.g., 0) will be regarded as non-craving.
Time frame: Alcohol craving was assessed during a laboratory alcohol-cue exposure paradigm, at week 5. Participants rated their alcohol craving immediately following exposure to alcohol and water cues. The outcomes measure is craving after alcohol cue exposure.
| Milestone | Atomoxetine | Placebo |
|---|---|---|
| Started | 21 | 21 |
| Completed | 17 | 18 |
| Not completed | 4 | 3 |
Number and percentage of youth who complete the active medication phase will determine feasibility.
| Participants | Atomoxetine | Placebo |
|---|---|---|
| Completion Rates | 17 | 18 |
The Client Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8 to 32 (higher scores indicate higher satisfaction), will determine acceptability. Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the CSQ-8 is ≥ 80%.
| Participants | Atomoxetine | Placebo |
|---|---|---|
| Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8 | 21 | 19 |
The primary measure of alcohol craving is the number and percentage of participants who report any level of alcohol craving during a laboratory alcohol-cue exposure paradigm using the following single item: How strong is your craving to drink alcohol? Scores range from 0 (None) to 20 (Extremely Strong). Individuals who endorse any level of alcohol craving (e.g., \> 1) are considered to experience craving. Individuals who do not report any alcohol craving (e.g., 0) will be regarded as non-craving.
| Participants | Atomoxetine | Placebo |
|---|---|---|
| Alcohol Craving | 5 | 16 |
Collected over Adverse events were collected during the 6-week treatment period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Atomoxetine | 0/21 (0%) | 0/21 (0%) | 19/21 (90.5%) |
| Placebo | 0/21 (0%) | 0/21 (0%) | 19/21 (90.5%) |
| Event | Atomoxetine | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 9/21 | 8/21 |
| HypertensionCardiac disorders | 8/21 | 6/21 |
| HeadacheGeneral disorders | 7/21 | 7/21 |
| Flu-like symptomsGeneral disorders | 4/21 | 5/21 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/21 | 5/21 |
| InsomniaGeneral disorders | 4/21 | 3/21 |
| Sore throatGeneral disorders | 2/21 | 4/21 |
| Nasal congestionGeneral disorders | 1/21 | 4/21 |
| DrowsinessGeneral disorders | 1/21 | 3/21 |
| AnxietyPsychiatric disorders | 3/21 | 0/21 |
| Age, Continuous(Years) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Mean | 18.8 ± 0.8 | 18.9 ± 0.7 | 18.9 ± .08 |
| Sex: Female, Male(Participants) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 10 | 10 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 10 |
| Not Hispanic or Latino | 15 | 17 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 5 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 0 | 6 |
| White | 13 | 15 | 28 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
| Days Abstinent from Alcohol (% of Days)(Percent of Days) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Mean | 65.65 ± 10.26 | 61.57 ± 16.67 | 63.61 ± 13.82 |
| Number of Standard Alcohol Drinks per Drinking Day(Drinks per Drinking Day) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Mean | 5.57 ± 2.45 | 4.72 ± 1.96 | 5.14 ± 2.23 |
| Heavy Drinking Days (%)(Percent of Days) | Atomoxetine | Placebo | Total |
|---|---|---|---|
| Mean | 26.02 ± 10.69 | 27.89 ± 12.61 | 26.96 ± 12.05 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be uploaded into the appropriate NIH repository as required.
Supporting information: Sap, Icf, Analytic code
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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