Behavioral Therapy + Memantine for Skin Picking Disorder

Overseen By Laurie Avila, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Chicago

Disqualifiers: Psychosis, Bipolar, Mania, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments for individuals with trichotillomania (a condition characterized by a strong urge to pull out hair) or skin picking disorder. Participants will first take memantine, a medication, for 8 weeks, followed by 8 weeks of ComB therapy, which aims to change behavior. The trial aims to determine which treatment is more effective and whether both improve symptoms. Individuals diagnosed with trichotillomania or skin picking disorder who have maintained a stable medication routine for at least 3 months may qualify to participate. As a Phase 2, Phase 3 trial, this research evaluates treatment effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to significant advancements in care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose for at least the past 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have tested memantine for safety and shown promising results. The FDA has already approved it for treating Alzheimer's disease, indicating it is generally well-tolerated. Research shows that memantine was safe and more effective than a placebo in reducing symptoms of skin-picking and hair-pulling disorders.

Doctors commonly use Comprehensive Behavioral (ComB) Therapy to treat these disorders. This therapy does not involve medication, typically resulting in fewer side effects.

Both treatments appear safe based on current evidence, but it is important to consult a healthcare provider about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this treatment for skin picking disorder because it combines a medication, memantine, with a behavioral approach, ComB therapy. Memantine is typically used to treat Alzheimer's disease and works by blocking certain brain receptors that are thought to play a role in compulsive behaviors, which is different from the usual treatments that often focus solely on behavioral or habit-reversal techniques. This dual approach aims to target the disorder both neurologically and behaviorally, offering a comprehensive treatment plan that might be more effective than current options. The use of memantine could help reduce urges, while ComB therapy provides strategies to manage and alter the behavior, potentially leading to more sustained improvement.

What evidence suggests that this trial's treatments could be effective for skin picking disorder?

Research has shown that Comprehensive Behavioral (ComB) therapy effectively treats skin picking disorder. In one study, nearly half of the participants completely stopped their symptoms, and another 27.6% showed some improvement. This indicates that ComB therapy can significantly help many people reduce their symptoms.

Memantine, a medication, also shows promise. In a study, 60.5% of people taking memantine felt "much or very much improved," compared to just 8.3% in the placebo group. Additionally, 43.8% of patients noticed a significant improvement in their symptoms after treatment. In this trial, participants will first receive memantine treatment followed by ComB therapy. Both treatments have shown potential in helping those with skin picking disorder. ^{1 5 6 7 8}

Who Is on the Research Team?

Jon E Grant, MD

Principal Investigator

University of Chicago

Gregory Chasson, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for adults 18+ with Trichotillomania or Skin Picking Disorder who can consent to participate. They must have a stable medication dose for the past 3 months and meet certain diagnostic criteria.

Inclusion Criteria

I have been diagnosed with a disorder that makes me pull out my hair or pick my skin.

My medication doses have not changed in the last 3 months.

I can understand and sign the consent form.

Exclusion Criteria

Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS)

My drug test for illegal substances was negative.

I can understand and manage my medication, and I can give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Memantine Treatment

Participants receive memantine treatment for 8 weeks, starting with 10mg daily for the first two weeks, then 20mg daily for the remaining six weeks

8 weeks

Weekly visits (in-person)

Washout Period

A 4-week washout period where no treatment is administered

4 weeks

Comprehensive Behavioral Therapy (ComB)

Participants receive ComB therapy once a week for 30 minutes over 8 weeks

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ComB Behavioral Therapy
• Memantine

Trial Overview The study compares behavioral therapy (ComB) with Memantine, a drug, in treating Body Focused Repetitive Behaviors over 16 weeks. It tests if ComB leads to better outcomes than Memantine or if both show improvements.

How Is the Trial Designed?

Group I: Memantine and Behavioral Therapy Experimental Treatment 2 Interventions

All subjects will receive 8-weeks of memantine treatment (10mg po qday for the first two weeks, then 20 mg po qday for the remaining six weeks). After the 8-weeks of memantine treatment, the dose will be discontinued. Then, after a 4-week washout period, all subjects will receive 8-weeks of ComB therapy. Therapy will be once a week for 30 minutes. After the 8-weeks of ComB treatment, the therapy will be discontinued.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Memantine is a well-established treatment for Alzheimer's disease, acting as a noncompetitive antagonist of NMDA receptors, which helps relieve symptoms but does not cure the disease.

Since its introduction in 1989, memantine has become the second most commonly used dementia drug worldwide, highlighting its significance in managing Alzheimer's symptoms despite its limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic information about memantine and its treatment of Alzheimer's disease and other clinical applications. Tang, BC., Wang, YT., Ren, J.[2023]

In a 5-year study analyzing cognitive decline in Huntington's disease patients, memantine use did not show any significant clinical benefits compared to non-users.

The study utilized linear mixed effect models to compare memantine users and non-users, indicating that memantine may not be effective in altering the course of cognitive decline in Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine Use and Cognitive Decline in Huntington's Disease: An Enroll-HD Study. Ogilvie, AC., Schultz, JL.[2023]

Memantine is an NMDA receptor antagonist that has shown neuroprotective and cognition-enhancing effects in animal models, and it has been clinically effective in improving cognitive performance in patients with Alzheimer's disease and vascular dementia.

Clinical trials have demonstrated that memantine is well-tolerated, with a low incidence of adverse events, making it a safe option for treating moderately severe to severe Alzheimer's disease, leading to its approval in both Europe and the US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine hydrochloride: pharmacological and clinical profile. Möbius, HJ., Stöffler, A., Graham, SM.[2017]

Memantine is a unique NMDA receptor antagonist that selectively blocks harmful glutamate activity associated with Alzheimer's disease while preserving normal cognitive function, making it a promising treatment option.

Clinical studies have shown that memantine improves symptoms and slows clinical deterioration in patients with moderate-to-severe Alzheimer's disease, leading to its approval in the US in 2003.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of memantine for the treatment of Alzheimer's disease. Ferris, SH.[2019]

Memantine is a groundbreaking medication for moderate to severe Alzheimer's disease, acting as a moderate-affinity, uncompetitive NMDA receptor antagonist that helps to regulate glutamate activity in the brain.

Since its FDA approval in 2003, memantine has been shown to improve cognitive function, reduce behavioral issues, enhance daily living activities, and delay the need for institutional care in patients, especially when used alongside donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Classics in Chemical Neuroscience: Memantine. Alam, S., Lingenfelter, KS., Bender, AM., et al.[2022]

A 75-year-old woman with Huntington's disease showed significant improvement in involuntary movements (chorea) after being treated with memantine, a medication typically used for Alzheimer's disease.

The treatment not only suppressed her chorea but also slowed the progression of her symptoms over a 7-year period, suggesting that memantine may offer a potential therapeutic option for managing Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine administration prevented chorea movement in Huntington's disease: a case report. Saigoh, K., Hirano, M., Mitsui, Y., et al.[2023]

In a double-blind, randomized, placebo-controlled study involving 40 patients with OCD, the addition of memantine to standard treatment significantly reduced OCD symptoms compared to the placebo group over 12 weeks.

While both groups showed improvements in illness severity, the treatment group experienced a more pronounced decrease, indicating that memantine may enhance the effectiveness of existing OCD therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In a double-blind, randomized and placebo-controlled trial, adjuvant memantine improved symptoms in inpatients suffering from refractory obsessive-compulsive disorders (OCD). Haghighi, M., Jahangard, L., Mohammad-Beigi, H., et al.[2022]

Memantine is an uncompetitive NMDA receptor antagonist that helps reduce glutamatergic excitotoxicity, showing modest improvement in clinical symptoms and potentially slowing disease progression in moderate-to-severe Alzheimer's disease and other forms of dementia.

Unlike cholinesterase inhibitors, which only provide symptomatic relief, memantine has been effective in severe stages of dementia and is the first drug to completely eliminate pendular nystagmus in multiple sclerosis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine: pharmacological properties and clinical uses. Kumar, S.[2013]

Combination therapy with serotonin reuptake inhibitors (SRIs) and memantine (MEM) significantly improved treatment outcomes for obsessive-compulsive disorder compared to placebo, with a risk ratio of 0.22 and a number needed to treat of 2 based on data from three randomized controlled trials involving 97 participants.

The combination therapy also led to significant reductions in scores on the Yale-Brown Obsessive-Compulsive Scale, including both obsession and compulsion subscales, without any notable safety concerns between the treatment and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapy of Serotonin Reuptake Inhibitors and Memantine for Obsessive- Compulsive Disorder: A Meta-Analysis of Double-Blind, Randomized, Placebo-Controlled Trials. Kishi, T., Matsuda, Y., Iwata, N.[2022]

In an 8-week open-label trial with 12 individuals suffering from kleptomania, memantine treatment led to significant reductions in kleptomania severity, with 91.7% of participants showing marked improvement.

Memantine was well tolerated and also improved mood, anxiety, and impulsivity, suggesting it may be an effective pharmacological option for managing kleptomania and its associated behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Memantine reduces stealing behavior and impulsivity in kleptomania: a pilot study. Grant, JE., Odlaug, BL., Schreiber, LR., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8683380/

Extended follow-up of a comprehensive behavioral (ComB ... This study provides the longest follow-up yet for comprehensive behavioral (ComB) treatment of trichotillomania (TTM)

2. iocdf.org iocdf.org/expert-opinions/comprehensive-behavioral-comb-treatment-for-skin-picking-and-hair-pulling-disorders/

Comprehensive Behavioral (ComB) Treatment for Skin ... This article will focus on the therapy approach called Comprehensive Behavioral (ComB) treatment — an approach that is favored by many clinicians ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364923000313

Self-help for body-focused repetitive behaviors The present study examined efficacy of three behavioral self-help techniques to reduce BFRBs: habit reversal training (HRT), decoupling (DC), and decoupling in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5522672/

Excoriation (skin-picking) disorder: a systematic review of ... In this trial (n=29), almost half of the sample (44.8%) showed full remission of picking symptoms, with an additional 27.6% showing partial ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0738081X23000317

Addressing body-focused repetitive behaviors in the ... Habit reversal therapy in the management of body focused repetitive behavior disorders ... Comprehensive Behavioral Treatment for Hair Pulling and Skin Picking.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05796752

Behavioral Treatment and Memantine in Body Focused ... Therefore, the current trial aims to compare the efficacy of behavioral therapy and memantine in adults with trichotillomania and skin picking disorder.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178123000732

Characteristics of trichotillomania and excoriation disorder ... Trichotillomania (hair-pulling disorder) and excoriation (skin-picking) disorder are body-focused repetitive behaviors, which often first present in ...

8. adaa.org adaa.org/learn-from-us/from-the-experts/blog-posts/professional/tackling-picking-and-pulling-all-angles-comb

Tackling Picking and Pulling from all Angles - the ComB ... What are BFRBs? Body focused repetitive behaviors or BFRBs are more commonly called skin picking or hair pulling disorders.