Withdrawal SymptomsNCT02044757
The Potentially Addictive Properties of Soda: A Feasibility Study
A study testing SSB withdrawal in people with Withdrawal Symptoms, run by University of California, Berkeley at 1 site in United States.
Trial summary
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Withdrawal Symptoms
- What is being tested?
- SSB withdrawal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Drinks more than 36 ounces of sugar-sweetened beverages per day
- Speaks fluent English
- Parent speaks English or Spanish
- Lives in San Francisco Bay Area
Who cannot join
- Pregnant or nursing
- Taking medication to address mental health issues
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital and Reasearch Center Oakland
Oakland, California, 94609
About this study
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.
- Conditions
- Withdrawal Symptoms
- Being tested
- SSB withdrawal
- Keywords
- Caffeine, Addiction, Withdrawal symptoms, Pediatric, Adolescent, Overweight
- Medical subject headings
- Substance Withdrawal Syndrome, Behavior, Addictive, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSB withdrawalBehavioural
During days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8).
| Study group | Role | What they receive |
|---|---|---|
| SSB withdrawal | Experimental | Not described Receives: Behavioral: SSB withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of withdrawal
Symptoms of withdrawal during the SSB withdrawal period (days 6-8) will be compared to symptoms of withdrawal during usual consumption period (days 1-3). Three measures are used to assess withdrawal symptoms: Griffiths' withdrawal scale, the relative reinforcing value of soda, and daily check in questions on well-being.
Measured: Days 1-3 and days 6-8
Secondary outcomes (4)
Change in diet
Changes in diet will be assessed by 24-hour dietary recalls and beverage recalls
Measured: Days 1-2, 6-8
Change in impulsivity
Impulsivity will be assessed via the delayed discounting task
Measured: Days 1 and 8
Change in stress
Stress will be assessed via salivary cortisol samples
Measured: Days 1 and 8
Change in preference for soda
Preference for soda will be measured through the Labeled Affective Magnitude Scale (LAMS) and daily check-in questions
Measured: Days 1-3, 6-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Withdrawal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Kristine A Madsen, MD, MPH, Principal investigator, University of California, Berkeley School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044757
- Sponsor's protocol ID
- 12-08545
- Other IDs
- 6030sc
- Status last verified
- Dec 2014
- First submitted
- 22 Jan 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potentially Addictive Properties of Soda: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02044757
- Acronym / sponsor ID
- 12-08545
- Conditions
- Withdrawal Symptoms
- Keywords
- Caffeine, Addiction, Withdrawal symptoms, Pediatric, Adolescent, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Jun 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study to investigate the addictive properties of soda and other sugar sweetened beverages (SBBs) in teenagers aged 13-18 years. It is hypothesized that participants who were regularly consuming sweetened and caffeinated beverages will experience symptoms typical of caffeine withdrawal, such as headache and fatigue, during the SSB withdrawal period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSB withdrawal | Experimental | Behavioral: SSB withdrawal |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Drinks more than 36 ounces of sugar-sweetened beverages per day
- Speaks fluent English
- Parent speaks English or Spanish
- Lives in San Francisco Bay Area
Key exclusion criteria (2 listed)
- Pregnant or nursing
- Taking medication to address mental health issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SSB withdrawalDuring days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8). | Behavioural | SSB withdrawal |
Primary outcome
Symptoms of withdrawal
Time frame: Days 1-3 and days 6-8
Symptoms of withdrawal during the SSB withdrawal period (days 6-8) will be compared to symptoms of withdrawal during usual consumption period (days 1-3). Three measures are used to assess withdrawal symptoms: Griffiths' withdrawal scale, the relative reinforcing value of soda, and daily check in questions on well-being.
4 secondary outcomes
Change in diet
Time frame: Days 1-2, 6-8
Change in impulsivity
Time frame: Days 1 and 8
Change in stress
Time frame: Days 1 and 8
Change in preference for soda
Time frame: Days 1-3, 6-8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine A Madsen, MD, MPH principal investigator
University of California, Berkeley School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSB withdrawal in people with Withdrawal Symptoms, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of withdrawal (time frame: Days 1-3 and days 6-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.