Trial Outcomes & Findings for Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine (NCT NCT04565288)

NCT ID: NCT04565288

Last Updated: 2025-05-09

Results Overview

Number and percentage of youth who complete the active medication phase will determine feasibility.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 6-week active treatment phase
• Results posted on: 2025-05-09

Participant Flow

Participant milestones

Measure	Atomoxetine Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial	Placebo Identical matching placebo capsules
Overall Study STARTED	21	21
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

Baseline characteristics by cohort

Measure	Atomoxetine n=21 Participants Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial	Placebo n=21 Participants Identical matching placebo capsules	Total n=42 Participants Total of all reporting groups
Age, Continuous	18.8 Years STANDARD_DEVIATION 0.8 • n=5 Participants	18.9 Years STANDARD_DEVIATION 0.7 • n=7 Participants	18.9 Years STANDARD_DEVIATION .08 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	21 participants n=7 Participants	42 participants n=5 Participants
Days Abstinent from Alcohol (% of Days)	65.65 Percent of Days STANDARD_DEVIATION 10.26 • n=5 Participants	61.57 Percent of Days STANDARD_DEVIATION 16.67 • n=7 Participants	63.61 Percent of Days STANDARD_DEVIATION 13.82 • n=5 Participants
Number of Standard Alcohol Drinks per Drinking Day	5.57 Drinks per Drinking Day STANDARD_DEVIATION 2.45 • n=5 Participants	4.72 Drinks per Drinking Day STANDARD_DEVIATION 1.96 • n=7 Participants	5.14 Drinks per Drinking Day STANDARD_DEVIATION 2.23 • n=5 Participants
Heavy Drinking Days (%)	26.02 Percent of Days STANDARD_DEVIATION 10.69 • n=5 Participants	27.89 Percent of Days STANDARD_DEVIATION 12.61 • n=7 Participants	26.96 Percent of Days STANDARD_DEVIATION 12.05 • n=5 Participants

PRIMARY outcome

Timeframe: 6-week active treatment phase

Number and percentage of youth who complete the active medication phase will determine feasibility.

Outcome measures

Measure	Atomoxetine n=21 Participants Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial Atomoxetine: 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).	Placebo n=21 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Completion Rates	17 Participants	18 Participants

PRIMARY outcome

Timeframe: 6-week active treatment phase

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%.

Outcome measures

Measure	Atomoxetine n=21 Participants Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial Atomoxetine: 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).	Placebo n=21 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8	21 Participants	19 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Atomoxetine n=11 Participants Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial Atomoxetine: 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).	Placebo n=18 Participants Identical matching placebo capsules Placebo: Matching placebo (sugar pill)
Alcohol Craving	5 Participants	16 Participants

Adverse Events

Atomoxetine

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Atomoxetine n=21 participants at risk Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial	Placebo n=21 participants at risk Identical matching placebo capsules
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	23.8% 5/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Gastrointestinal disorders Nausea	42.9% 9/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	38.1% 8/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Cardiac disorders Hypertension	38.1% 8/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	28.6% 6/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Headache	33.3% 7/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	33.3% 7/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Flu-like symptoms	19.0% 4/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	23.8% 5/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Insomnia	19.0% 4/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	14.3% 3/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Sore throat	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	19.0% 4/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Nasal congestion	4.8% 1/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	19.0% 4/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Gastrointestinal disorders Decreased appetite	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Drowsiness	4.8% 1/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	14.3% 3/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Psychiatric disorders Anxiety	14.3% 3/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	0.00% 0/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Fever	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	4.8% 1/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Gastrointestinal disorders Stomach pain	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	4.8% 1/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
General disorders Tingling	4.8% 1/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Gastrointestinal disorders Vomiting	14.3% 3/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	0.00% 0/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Metabolism and nutrition disorders Weight gain	0.00% 0/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	14.3% 3/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Cardiac disorders Heart racing	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	0.00% 0/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)
Metabolism and nutrition disorders Increased appetite	0.00% 0/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)	9.5% 2/21 • Adverse events were collected during the 6-week treatment period. Adverse events were captured using criteria set forth by the U.S. Food and Drug Adminisration (FDA)

Additional Information

Dr. Robert Miranda Jr.

Brown University

Phone: 401-863-6658

Email: Robert_Miranda_Jr@brown.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place